Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Notices 17195

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Director of CBER (21

CFR 5.67).

Dated: March 27, 1997.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 97–8987 Filed 4–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Statement of Organization, Functions,

and Delegations of Authority

Part D, Chapter DB (Office of

Operations) of the Statement of

Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services (35 FR 3685, February 25,

1970, and 60 FR 56605, November 9,

1995, and in pertinent part at 56 FR

50126, October 3, 1991) is amended to

reflect the reorganization of the Center

for Veterinary Medicine (CVM), Office

of Operations, in the Food and Drug

Administration (FDA).

The Center for Veterinary Medicine

will continue to develop and

recommend the veterinary medical

policy of the Agency with respect to the

safety and effectiveness of animal drugs,

feeds, feed additives, veterinary medical

devices (medical devices for animal

use), and other veterinary medical

products. The restructuring of the

Center is proposed to strengthen the

delivery of services to our constituents

and customer groups by streamlining

the organization through delayering

lines of authority and responsibility,

and improving channels of

communications at all levels within the

Center.

1. Delete Office of the Center Director

(HFV1), Center for Veterinary Medicine

(HFV), in its entirety and replace with

the following:

Office of the Center Director (DBVA).

Directs overall Center activities and

coordinates and establishes Center

policy in the areas of research,

management, scientific evaluation,

compliance and surveillance.

Approves new animal drug

applications and issues notices of

withdrawal of new animal drug

approvals when the opportunity for a

hearing has been waived.

Authorizes for use as edible products

animals treated with investigational

drugs and terminates exemptions for

investigational trials. In conjunction

with appropriate agency officials in the

foods area, provides FDA policy

development and direction on

environmental impact matters.

Serves as focal point for operational

review and compliance activity policy

and legislative matters; serves as focal

point for international harmonization

and trade issues related to animal drugs

and feeds; leads and provides oversight

of research animal issues for FDA.

Plans, develops and implements the

Center’s Equal Employment

Opportunity and Affirmative Action

Program.

Develops, reviews, and coordinates all

Federal Register publications pertaining

to Center functions and coordinates

requests and activities pertaining to the

Regulatory Flexibility Act, Executive

Orders on Regulations, Paperwork

Reduction Act, and regulations planning

and implementation.

2. Delete the Office of Management

(HFV1A), Center for Veterinary

Medicine (HFV), in its entirety and

replace with the following:

Office of Management and

Communications (DBVB). Provides

guidance and leadership in the analysis,

planning, coordination and evaluation

of administrative management activities

including: personnel; employee

orientation and development;

procurement; travel; facilities; property;

security; records management;

performance management; awards;

budget formulation and execution;

information resources management;

program analysis; and management

analysis. Provides administrative

assistance and support to the Veterinary

Medicine Advisory Committee (VMAC)

Executive Secretary.

Plans, develops, and implements

Center management policies. Provides

leadership and direction for the

management and administrative

interface with the Agency, the

Department and other Federal agencies.

Serves as Center interface with the

Agency and Department on budget issue

resolutions.

Performs analysis, program

assessments, or special studies of key

issues relative to policy review and

oversight. Directs a variety of shortrange and long-range special projects or

assignments of substantial significant to

the Center.

Implements Internal Control Reviews

in accordance with the Office of

Management and Budget, Department

and Agency guidelines. Provides

direction in the preparation of responses

to the Office of Inspector General and

the General Accounting Office regarding

audits and investigation.

Directs the Center’s outreach efforts to

consumers, professionals and the

industry in communicating the program

goals and priorities of the Center.

Maintains the CVM Home Page on the

World Wide Web. Provides automated

scientific literature searches and

retrieval support. Supports public and

consumer affairs, including freedom of

information.

Directs the Center’s Strategic Plan and

the efforts of Strategic Implementation

Groups (SIG) to effectively accomplish

Center goals and objectives. Facilitates

implementation of SIG

recommendations.

3. Insert Administrative Staff (DBVB–

1), under the Office of Management and

Communications (DBVB), reading as

follows:

Administrative Staff (DBVB–1). Serves

as the focal point in the Center for

administrative management activities.

Coordinates the administrative

management activities in the Offices

with designated Administrative

Officers, i.e., personnel management,

property acquisition and surplus,

inventory, procurement, travel services,

security procedures, records

management, performance management,

conflict of interest, special government

employees, and telecommunications.

Safeguards the administrative

management services against waste,

fraud and abuse.

Manages the Center’s award systems

through the Strategic Plan Awards

Committee and the CVM Incentive

Awards Committee. Manages CVM’s

participation in the Agency’s Honor

Award process, including the first and

second tier ceremonies.

Provides budget execution and fiscal

accounting services for the Center.

Monitors and provides officials with

continual awareness of obligated

commitments and status of funds.

Directs, develops and implements the

Center’s overall professional, scientific,

technical, clerical, and management

training programs; formal career

development programs and New

Employee Orientation Program.

Coordinates all Special training

programs from the Agency and

Department.

4. Insert Communications Staff

(DBVB–2), under the Office of

Management and Communications

(DBVB), reading as follows:

Communications Staff (DBVB–2).

Plans, produces, and publishes a

bimonthly subscription newsletter

entitled the FDA VETERINARIAN and

other publications such as CVM

UPDATES and consumer fliers.

Supports FDA public affairs/

consumer affairs initiatives, including
17196 Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Notices

supporting the efforts of CVM’s Press

Officer and FDA Public Affairs

Specialists in headquarters and the

field.

Develops, prepares, and coordinates

the Center’s responses to requests for

information through the Freedom of

Information Act (FOIA).

Provides automated, scientific

literature search capabilities and

retrieval support to CVM. Keeps the

Center current on improvements to

these systems.

Delivers the Center’s message to our

customers, both inside and outside

government, through the most effective

and up-to-date medial technologies

available, including the World Wide

Web, the Internet, etc.

Establishes and coordinates industry/

producer group outreach initiatives.

Responds to inquiries to the Center,

including letters and telephone

inquiries from consumers, industry

representatives, government officials,

health professionals and academics.

5. Insert Program Planning and

Evaluation Staff (DBVB–3), under the

Office of Management and

Communications (DBVB), reading as

follows:

Program Planning and Evaluation

Staff (DBVB–3). Prepares the Agency

annual budget estimates. This includes

all phases of budget analysis and

formulation and presentation. Assists

staff in justifying budgets for anticipated

needs.

Conducts management and program

analysis studies and participates in the

program planning process to identify

operational goals and evaluation

methods. Designs and recommends

systems and procedures and develops

policy recommendations to implement

study conclusions.

Provides management and consulting

services, including policy development

and analysis of proposed policy

changes. Assists Center managers in

assessing management problems and

designs and recommends systems and

procedures; develops and recommends

policy to implement study conclusions.

Conducts Internal Control Reviews in

accordance with instructions and

guidelines provided by Agency and

OMB. Conducts analysis and presents

summary of findings to management

officials. Assists in the coordination and

preparation of responses to the Office of

the Inspector General and the General

Accounting Office regarding audits and

investigations.

6. Insert Information Resources

Management Staff (DBVB–4), under the

Office of Management and

Communications (DBVB), reading as

follows:

Information Resources Management

Staff (DBVB–4). Implements information

resources management functions for the

Center including systems development,

systems management,

telecommunications plan and ADP

security.

Provides systems analysis and

programming support for the Center.

Directs the utilization of the Center’s

central computer system and the

internal network of personal computers

and video display terminals.

Provides user support for all functions

involving the CVM local area network

and wide area network.

Provides support and training on ADP

security including implementation of

the FDA and DHHS security

requirements.

7. Delete Office of New Animal Drug

Evaluation (HFVT), Center for

Veterinary Medicine (HFV), in its

entirety and replace with the following:

Office of New Animal Drug

Evaluation (DBVC). Evaluates for animal

safety and effectiveness new animal

drugs in pharmaceutical dosage forms or

for use in animal feed, and the safety

aspects of drug and food additive

residues remaining in food produced for

human consumption from animals,

intentionally or otherwise, administered

drugs or food additives.

Reviews and determines the adequacy

of information submitted in support of

proposed use of investigational new

animal drugs, and recommends to the

Center Director appropriate action on

new animal drug applications and acts

on investigational new animal drug

(INAD) notices of exemption and

authorization requests.

Evaluates manufacturing methods and

procedures for new animal drug

products.

Coordinates the development and

implementation of regulations and

policies pertaining to new drugs

intended for animal use.

Evaluates office activities to ensure

compliance with the National

Environmental Policy Act (NEPA).

Provides technical support and expert

testimony in legal proceedings relative

to the approval of new animal drugs.

Participates in international activities

designed to harmonize the drug

approval process.

8. Delete the Office of Surveillance

and Compliance (HFVU), Center for

Veterinary Medicine (HFV), in its

entirety and replace with the following:

Office of Surveillance and

Compliance (DBVD). Advises the Center

Director on surveillance and compliance

policy concerning FDA regulatory

responsibility with respect to animal

drugs, feeds, feed additives, veterinary

medical devices, and other veterinary

medical products.

Develops and evaluates surveillance

and monitoring programs to ensure the

safety and effectiveness of animal drugs

and to detect emerging resistance to

antimicrobials among zoonotic enteric

pathogens.

Plans, develops, monitors, and

evaluates Center surveillance and

compliance programs and coordinates

their field implementation to ensure the

safety and effectiveness of marketed

animal drugs, feeds, feed additives,

veterinary medical devices, and other

veterinary medical products.

Directs and coordinates the

development of scientific evidence

supporting Formal Evidentiary Hearings

requested by the Center.

Recommends to the Center Director

the amendment or withdrawal of

approved new animal drugs

applications.

Develops, coordinates, and directs the

Center’s Bioresearch Monitoring

Program to ensure reliability of

information on which to base new

animal drug and food additive

approvals.

Provides epidemiology expertise to

the Center as needed.

9. Delete the Office of Science

(HFVV1), Center for Veterinary

Medicine (HFV), in its entirety and

replace with the following:

Office of Research (DBVE). Advises

and assists the Center Director and other

officials on research matters which

affect Center policy direction and longrange goals.

Provides focal point for all research

activities in the Center, serves as the

liaison for intramural and extramural

research.

Provides scientific review, guidance,

and support for research activities

(extramural research, training, and

fellowship activities); serves as the

Center focal point for pre-award

coordination.

Evaluates and reviews the adequacy

of research resources; appraises the

technical aspects and contributions of

Center science programs.

Initiates, manages, and reviews Center

contracts, grants, cooperative

agreements, and interagency agreements

with regard to enhancing the Center

research and science program activities.

Evaluates and interprets results of

scientific research; initiates and

recommends action as appropriate to

implement policy changes.

10. Delete Administrative Staff

(HFVV2), under the Office of Science

(HFVV1), in its entirety and replace

with the following:
Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Notices 17197

Administrative Staff (DBVE–1).

Manages budget, property, space, and

acquisition of equipment and services

for intramural research programs.

Responsible for the maintenance,

repair, and construction of grounds,

buildings, and equipment, as applicable,

in support of intramural research

programs.

Develops and manages health, safety,

and chemical disposal required for

intramural research programs.

Produces, reviews, and tracks

correspondence, reports, and

manuscripts for the intramural research

program.

11. Prior Delegations of Authority.

Pending further delegations, directives,

or orders by the Commissioner of Food

and Drugs, all delegations of authority

to positions of the affected organizations

in effect prior to this date shall continue

in effect in them or their successors.

Dated: January 23, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–9053 Filed 4–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–207]

Agency Information Collection

Activities: Proposed Collection;

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, is publishing the

following summary of proposed

collections for public comment.

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: New Collection; Title of

Information Collection: Evaluation of

Five State Health Care Reform

Demonstrations and the Evaluation of

the Medicaid State Health Reform

Demonstrations; Form No.: HCFA–R–

207; Use: These evaluations will

investigate health care reform in ten

states that will implement or have

implemented demonstration programs

using Medicaid Section 1115 waivers.

The surveys will gather information to

answer questions regarding access to

health care, quality of care delivered,

satisfaction with health services, and

the use and cost of health services. The

surveys will be administered to

Medicaid eligible and newly covered

enrollees and eligible and near-eligible

non-enrollees. A subsample of survey

respondents will be SSI recipients and

other disabled people who have

participated in demonstrations for at

least a year. Quality of care surveys will

be administered to Medicaid enrollees

who have diabetes and to parents of

children in the Medicaid program who

have pediatric asthma. Frequency:

(Other) one time for most respondents;

Affected Public: Individuals or

Households; Number of Respondents:

60,483; Total Annual Responses:

60,691; Total Annual Hours: 18,267.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, 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 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Analysis and

Planning Staff, Attention: John Rudolph,

Room C2–26–17, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: April 1, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources.

[FR Doc. 97–9082 Filed 4–8–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Agency Information Collection

Activities: Proposed Collection:

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 proposals for the

collection of information. Interested

persons are invited to send comments

regarding this 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.

1. Type of Request: Extension of a

currently approved collection; Title of

Information Collection: Medicaid Drug

Rebate Program—Manufacturers; Form

No.: HCFA–367, 367 a, b, and c; Use:

Section 1927 requires drug

manufacturers to enter into and have in

effect a rebate agreement with the

Federal Government for States to receive

funding for drugs dispensed to

Medicaid recipients; Frequency:

Quarterly; Affected Public: Business or

other for-profit; Number of

Respondents: 520; Total Annual

Responses: 2,080; Total Annual Hours:

49,480.

2. Type of Request: Extension of a

currently approved collection; Title of

Information Collection: State Drug

Rebate (Medicaid); Form No.: HCFA–

368 and HCFA-R–144; Use: Section

1927 requires State Medicaid agencies

to report to drug manufacturers and

HCFA on the drug utilization for their

State and the amount of rebate to be

paid by the manufacturers; Frequency:

Quarterly; Affected Public: State, local,

or tribal government; Number of

Respondents: 51; Total Annual

Responses: 204; Total Annual Hours:

6,125.

To request copies of the proposed

paperwork collection referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)