38564 Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Notices

5600 Fishers Lane, Rockville, MD

20857, 301–594–6758, or

Toni M. Stifano, Center for Biologics

Evaluation and Research (HFM–

602), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448,

301–827–6190, e-mail:

stifano@cber.fda.gov.

SUPPLEMENTARY INFORMATION: As part of

a comprehensive effort to make

prescription drugs safer to use, FDA is

engaged in several initiatives to make

prescription drug labeling a better

information source for health care

practitioners—clearer, more

informative, more accessible, and more

consistent from drug to drug. FDA is

developing and intends to publish a

proposed rule to revise the overall

format of prescription drug labeling. It

will propose reordering the sections of

the labeling, based on the importance of

the information to practitioners, and the

frequency with which practitioners refer

to a section and creating a ‘‘highlights’’

section and an index.

FDA also is working on a proposed

rule to revise the current requirements

for the pregnancy subsection of labeling

(see 62 FR 41061, July 31, 1997,

announcing 21 CFR part 15 hearing to

discuss the category requirements, and

64 FR 23340, April 30, 1999,

announcing a public advisory

committee meeting to discuss possible

changes to pregnancy labeling).

In addition, FDA is developing

guidance documents that focus on the

content of certain labeling sections. The

draft guidance on ‘‘Content and Format

of the Adverse Reactions Section of

Labeling for Human Prescription Drugs

and Biologics’’ provides guidance on,

among other things, criteria for

including adverse reactions in labeling,

presentation of adverse reactions in a

table, and organization of the section.

This section exists in the current

labeling and is expected to continue to

exist when the new format for

prescription drug labeling is proposed.

At this time, FDA also is developing

guidances for the Clinical

Pharmacology, Clinical Studies, and

Warnings/Precautions sections. The

agency expects to publish these draft

guidances for comment in the coming

months. To date, the agency has focused

its efforts on these sections because they

typically contain large amounts of

important and complex information and

there have been significant variations in

their format and content across different

medical products. Guidances for other

labeling sections may be developed

later.

This draft guidance is being issued

consistent with FDA’s good guidance

practices (62 FR 8961, February 27,

1997). The draft guidance represents the

agency’s current thinking on the content

and format of the adverse reactions

section of labeling for human

prescription drugs and biologics. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in the brackets in

the heading of this document. The draft

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: June 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15633 Filed 6–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1336]

Draft Guidance for Industry: Pediatric

Oncology Studies in Response to a

Written Request; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Pediatric Oncology

Studies in Response to a Written

Request.’’ The draft guidance document

provides assistance to applicants

intending to respond to a written

request from FDA for pediatric studies

for a drug that may show potential

health benefits in children with cancer.

The draft guidance discusses the kind of

information applicants should include

in their pediatric studies, which, if

responsive to a written request, may

make the applicant’s drug eligible to

qualify for an additional 6 months of

marketing exclusivity. This guidance is

part of the agency’s pediatric initiative

to generate new knowledge to assist

practitioners in the care of children with

cancer and to help provide pediatric

patients early access to emerging new

drugs.

DATES: Submit written comments on the

draft guidance to ensure their adequate

consideration in preparation of the final

document by September 18, 2000.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Pediatric Oncology

Studies in Response to a Written

Request’’ to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857; or the

Manufacturers Assistance and

Communications Staff (HFM–42),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 208521448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section of

this document for electronic access to

the draft guidance.

FOR FURTHER INFORMATION CONTACT:

Terrie L. Crescenzi, Center for Drug

Evaluation and Research (HFD–

104), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

7337, FAX 301–827–2520, e-mail:

crescenzit@cder.fda.gov, or

Elaine C. Esber, Center for Biologics

Evaluation and Research (HFM–30),

Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852, 301–827–0641, FAX 301–

827–0644, e-mail:

esber@cber.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance for industry entitled

‘‘Pediatric Oncology Studies in

Response to a Written Request.’’ Section

111 of the Food and Drug

Administration Modernization Act of

1997 (the Modernization Act), signed

into law by President Clinton on

November 21, 1997, created section

505A of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 355a),

which permits certain marketing

applications to obtain an additional 6

months of marketing exclusivity if the

sponsor submits requested information

Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Notices 38565

relating to the use of the drug in the

pediatric population. The statute

permits the agency to issue a written

request for pediatric studies under

section 505A(a) or (c) of the act. A

written request is a specific document

in which the agency requests

submission of certain studies. The

studies are designed to provide

information on the health benefits of a

drug in the pediatric population.

Because the study of oncology drugs

in pediatric populations merits special

consideration, the agency is publishing

this guidance to assist sponsors who

wish to undertake pediatric oncology

studies.

This draft guidance is being issued

consistent with FDA’s good guidance

practices (62 FR 8961, February 27,

1997). The draft guidance represents the

agency’s current thinking on pediatric

oncology studies. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statute,

regulations, or both.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

III. Electronic Access

Copies of this draft guidance for

industry are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm, http://www.fda.gov/cder/

pediatrics, and at http://www.fda.gov/

cber/guidelines.htm.

Dated: June 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15629 Filed 6–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Statement of Organization, Functions,

and Delegations of Authority

This notice amends Part R of the

Statement of Organization, Functions

and Delegations of Authority of the

Department of Health and Human

Services (DHHS), Health Resources and

Services Administration (60 FR 56605

as amended November 6, 1995, as last

amended at 65 FR 12021–4 dated March

7, 2000).

This notice reflects the organizational

and functional changes in the Northeast

Field Cluster (RF1).

Section RF–10 Organization

The Northeast Field Cluster is headed

up by the Field Director who reports

directly to the Associate Administrator,

Office of Field Operations. The

Northeast Field Cluster is organized as

follows:

A. Immediate Office of the Field

Director (RF14)

B. Office of Data and Analysis (RF15)

C. Philadelphia Field Office (RF11)

D. Boston Field Office (RF12)

E. New York Field Office (RF13)

Section RF;–20 Function

Immediate Office of the Field Director

(RF14)

Serves as HRSA’s senior public health

official in the Northeast cluster,

providing liaison with State and local

health officials as well as professional

organizations; (2) provides input from

local, regional and state perspectives to

assist the Administrator and the

Associate Administrators in the

formulation, development, analysis and

evaluation of HRSA programs and

initiatives; (3) at the direction of the

Administrator and/or in conjunction

with the HRSA Associate

Administrators and the Associate

Administrator, Office of Field

Operations, coordinates the field

implementation of special initiatives

which involve multiple HRSA programs

and/or field offices (e.g., Border Health);

(4) assists with the implementation of

HRSA programs in the field by

supporting the coordination of

activities, alerting program officials of

potential issues and assessing policies

and service delivery systems; (5)

represents the Administrator in working

with other Federal agencies, state and

local health departments, schools of

public health, primary care associations

and organizations, community health

centers, and others in coordinating

health programs and activities; and (6)

exercises line management authority as

delegated from the Administrator for

general administrative and management

functions within the field structure.

Office of Data and Analysis (RF15)

Provides technical assistance,

consultation, training to Field Cluster

staff, grantees related to data systems,

planning, and evaluation; (2) serves as

focal point for States and Agency

grantees on data and data systems issues

related to HRSA program requirements;

(3) develops statistical profiles of HRSA

grantees in the region, and analysis of

Geographic Information Systems

profiles and other profiles developed by

federal, state and local agencies in the

region; (4) develops State profiles; (5)

conducts and disseminates, as

appropriate, trend analysis of financial

data, health indicators, and service data

to identify emerging trends among

HRSA grantees and health service

catchment areas in the Northeast; (6)

provides consultation and support to

private nonprofit organizations involved

in health care delivery around special

studies, research, and evaluation related

to health disparities; (7) analyzes

program related reports; and (8)

maintains Field Cluster program related

database.

Philadelphia Field Office (RF11)

Directs and coordinates field

development and implementation of

HRSA programs and activities in 5

states within the Northeast Field Cluster

designed to increase access, capacity,

and capabilities of local and state health

systems and programs serving the

underserved populations in the states

served by the cluster, including primary

care programs, maternal and child

health, HIV/AIDS, health facilities

construction under the Hill-Burton

Program, rural health, and other health

related programs in the cluster; (2)

provides continuous program

monitoring of HRSA health service

grants and contracts for compliance

with applicable laws, regulations,

policies, and performance standards; (3)

assists in the implementation and

monitors policies related to National

Health Service Corps scholarship and

loan repayment programs; (4) provides

for development, implementation, and

monitoring of the annual field work

plan related to assigned program areas,

including setting objectives responsive

to national and field priorities based on

guidance provided by appropriate

HRSA bureau components and assigns

division resources required to attain

these objectives; (5) coordinates with