25920 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Dated: May 5, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 95–11930 Filed 5–12–95; 8:45 am]

BILLING CODE 4160–01–F

Product and Establishment License

Applications, Refusal To File;

Establishment of Refusal to File

Oversight Committee

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

establishment of a standing oversight

committee in the Center for Biologics

Evaluation and Research (CBER) to

conduct periodic reviews of CBER’s use

of its refusal to file (RTF) practices on

product license applications (PLA’s)

and establishment license applications

(ELA’s). CBER’s RTF oversight

committee will examine RTF decisions

to assess consistency across CBER

offices and divisions in RTF decisions

and to determine whether the guidance

currently available to sponsors needs to

be revised.

ADDRESSES: Submit written requests for

single copies of the CBER RTF guidance

document to the Office of External

Affairs, Industry Liaison Staff (HF–50),

Food and Drug Administration, rm. 15–

61, 5600 Fishers Lane, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT: Jean

M. Olson, Center for Biologics

Evaluation and Research (HFM–635),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–594–3074.

SUPPLEMENTARY INFORMATION: The

importance to the public health of

getting new biological products on the

market as efficiently as possible has

made improving the biological product

evaluation process an FDA priority, as

evidenced by initiatives, such as the

following: (1) Procedures to expedite

marketing approval for therapies for

serious or life threatening illnesses (53

FR 41516, October 21, 1988; 57 FR

58942, December 11, 1992); (2)

procedures and policies to make such

therapies available prior to marketing

approval through mechanisms such as

the treatment investigational new drug

(52 FR 19466, May 22, 1987) and the

parallel track (57 FR 13250, April 15,

1992); (3) announcement of the

availability of a CBER RTF guidance

document for sponsors (58 FR 38770,

July 20, 1993); and (4) implementation

of a managed review process for PLA’s,

ELA’s, and supplements to PLA’s and

ELA’s. The managed review process

focuses on specific milestones or

intermediate goals so that a quality

review is conducted within specified

time periods. The establishment and

first meeting of CBER’s RTF oversight

committee, announced and described in

this notice, continue CBER’s effort to

promote the timely, efficient, and

consistent review of PLA’s and ELA’s.

CBER recognizes that the practice of

submitting incomplete or inadequate

PLA’s and ELA’s and then providing

additional information to FDA during

an extended review period is inherently

inefficient and wasteful of FDA

resources. Such practice is also unfair to

those sponsors who fulfill their

scientific and legal obligations by

submitting complete applications; the

review of complete applications may be

delayed while incomplete applications,

submitted earlier, undergo review and

repair.

By means of an RTF notification,

CBER in general declines to file a

sponsor’s PLA or ELA because of

omissions or inadequacies so severe as

to render the application incomplete on

its face. Although not a final

determination, an RTF decision is a

significant step that delays, at least for

a time, full review of an application.

CBER believes that an RTF decision is,

in general, of benefit to sponsors as an

early signal that the application has

major deficiencies.

FDA regulations on filing PLA’s and

ELA’s are found in §§ 601.2(a) and 601.3

(21 CFR 601.2(a) and 601.3). A sponsor

who receives an RTF notification may

request an informal conference with

CBER, and thereafter the sponsor may

ask that the application be filed over

protest, similar to the procedure for

drugs described under § 314.101(a)(3)

(21 CFR 314.101(a)(3) (see 57 FR 17950,

April 28, 1992).

CBER has formed a standing RTF

oversight committee, consisting of

senior CBER officials, a senior official

from FDA’s Center for Drug Evaluation

and Research, and FDA’s Chief Mediator

and Ombudsman. Meetings will be held

once a quarter to review all of the RTF

decisions. The purpose of such a review

is to assess the consistency within CBER

in rendering RTF decisions and to

determine whether the currently

available guidance provided to sponsors

needs to be revised or supplemented.

Because the committee’s deliberations

will deal with confidential commercial

information, all meetings will be closed

to the public. The committee’s

deliberations will be reported in the

minutes of the meeting. Although those

minutes will not be publicly available

because they will contain confidential

commercial information, summaries of

the committee’s deliberations, with all

such confidential commercial

information omitted, will be available

from the FDA Chief Mediator and

Ombudsman. If, following the

committee’s review, an RTF decision

changes, the reviewing division will

notify the sponsor of the change.

Dated: May 5, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–11827 Filed 5–12–95; 8:45 am]

BILLING CODE 4160–01–F

International Scientific Conference on

Viral Safety and Evaluation of Viral

Clearance From Biopharmaceutical

Products; Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Center for

Biologics Evaluation and Research

(CBER), is announcing a meeting to

discuss viral safety of

biopharmaceutical products. FDA is

cosponsoring the meeting with the

National Institute of Allergy and

Infectious Diseases (NIAID), the U.S.

Department of Agriculture (USDA), the

National Vaccine Program Office

(NVPO), and the International

Association of Biological

Standardization (IABS). The meeting is

intended to provide an exchange of

information related to the viral safety of

biological products, including

information relevant to an International

Conference on Harmonization (ICH)

guideline on viral testing and validation

that is presently under development.

DATES: The public meeting will be held

on June 14 and 15, l995, from 8:30 a.m.

to 5 p.m., and on June 16, 1995, from

8:30 a.m. to 3:30 p.m. Participants may

pick up their information packages and

badges for admission to the sessions

beginning at approximately 7:30 a.m.

each morning.

ADDRESSES: The public meeting will be

held at the National Institutes of Health,

Bldg. 45, Main Auditorium of the

Natcher Conference Center, 9000

Rockville Pike, Bethesda, MD. There is

no registration fee for this meeting.

Space is limited, and all interested

parties are encouraged to register early

(see the contact person listed below).

FOR FURTHER INFORMATION CONTACT:

For information regarding registration,

housing, and other arrangements:

Tammy Lowry, KRA Corp., 1010 Wayne
Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25921

Ave., suite 850, Silver Spring, MD

20910, 301–495–1591, FAX 301–495–

9410.

For other information: William Freas,

Scientific Advisors and Consultants

Staff (HFM–21), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

0314, FAX 301–827–0294.

SUPPLEMENTARY INFORMATION: The

purpose of this meeting is to present

and discuss the available scientific

evidence and experience relating to:

Characterization of cell substrates for

the presence of viruses, evaluation of

virus removal and inactivation, and

other issues relating to viral

characterization. The symposium will

discuss in detail topics related to the

viral safety of biological products,

including topics relevant to an ICH

international guideline on viral testing

and validation that is presently under

development.

Plenary sessions will be held on the

mornings of June 14, 15, and 16, 1995.

Concurrent technical breakout sessions

will be held on the afternoons of June

14 and 15, l995.

Dated: May 9, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–11828 Filed 5–12–95; 8:45 am]

BILLING CODE 4160–01–F

Office of the Secretary

Grants and Cooperative Agreements;

Availability, etc.: Managed Care Impact

on People With Significant Physical

and Mental Disabilities

AGENCY: Office of the Assistant

Secretary for Planning and Evaluation

(ASPE), Department of Health and

Human Services (HHS).

ACTION: Request for applications to

conduct research to better understand

the impact of managed care on people

with significant physical and mental

disabilities. Projects will analyze

existing data sets to explore issues of

utilization, access, quality, costs and

outcomes for people with disabilities in

managed care systems. In addition,

where possible proposed applications

shall capitalize on linking state and

local data sets containing data on

functioning and health status for

disabled individuals to utilization and

cost data. For purposes of applications

requested under this announcement,

‘‘individuals with disabilities’’ includes

those under the age of 64 with ongoing

conditions or chronic illnesses of such

severity that they result in a need for

extra or specialized health services or

assistance with daily living tasks.

Specific groups of disabled individuals

included in this definition are children

and working aged adults 18–65 with

physical disabilities, mental retardation,

developmental disabilities and

persistent mental illness.

SUMMARY: The primary goal of this grant

announcement is to support research

which employs the analysis of existing

data and experience to inform policies

related to disability and managed health

care. Data sets which permit the

Department to compare the service use,

expenditures and outcomes of children

and working age adults (18–64) with

disabilities in managed care with

similar persons in the fee-for-service

system or that allow for an assessment

of utilization and costs prior to and

following managed care enrollment are

of particular interest. Such data sets

could include information from:

Medicaid management information

systems; community provider networks

including community health centers;

private insurers and health plans;

employers; social security records;

hospital records and other accessible

data sets which contain relevant

analytical variables. These projects are

intended to foster new analyses of

existing data sources by encouraging the

use of data sets from states, local areas,

or facilities in order to address issues of

quality, cost, access and outcomes. We

estimate that the scope and level of

effort will require from 12 to 24 months

to accomplish.

DATES: The closing date for submitting

applications under this announcement

is July 14, 1995.

ADDRESSES: Send application to Grants

Officer, Office of the Assistant Secretary

for Planning and Evaluation,

Department of Health and Human

Services, ASPE/IO, 200 Independence

Avenue, SW., Room 405F, Hubert H.

Humphrey Building, Washington, DC

20201. Attention: Albert A. Cutino,

Grants Officer.

FOR FURTHER INFORMATION CONTACT:

Application Instructions and Forms

should be requested from and submitted

to: Grants Officer, Department of Health

and Human Services, ASPE/IO, 200

Independence Avenue, SW., Room

405F, Hubert H. Humphrey Building,

Washington, DC 20201, Telephone:

(202) 690–8794. Requests for Forms will

be accepted and responded to up to 30

days prior to closing date of receipt of

Applications. Technical questions

should be directed to Andreas Frank or

Kevin Hennessy, ASPE/IO, Telephone

(202) 690–6443 or (202) 690–7272.

Questions also may be faxed to (202)

401–7733. Written technical questions

should be addressed to Dr. Hennessy or

Mr. Frank at the above address.

(Application submissions may not be

faxed.)

ELIGIBLE APPLICANTS: The Department

seeks applications from universities,

post-secondary degree granting entities,

managed care organizations, private

employers and insurers, and other

independent researchers. (For-profit

organizations are advised that no grant

funds may be paid as profit to any

recipient of a grant or subgrant.) Profit

is any amount in excess of allowable

direct and indirect costs of the grantee.

SUPPLEMENTARY INFORMATION:

Part I

Legislative Authority

This cooperative agreement is

authorized by Section 1110 of the Social

Security Act (42 U.S.C. 1310) and

awards will be made from funds

appropriated under Public Law 103–112

(DHHS Appropriations Act for FY

1995).

Project History and Purpose

Rising health care expenditures have

attracted considerable attention and

concern over the past decade. Of

particular concern to state and federal

governments, Medicaid spending had

increased from $41 billion in 1985 to

$138 billion by 1994. In an effort to

control spiraling Medicaid costs, states

are increasingly turning to managed

care, with estimates that approximately

25% of current Medicaid recipients are

covered by a form of managed care,

although participation remains

concentrated in a relatively few states.

With the demise of national health care

reform this trend is expected to

accelerate.

Over 93% of Medicaid payments are

now made on a fee-for-service basis.

Why is such a small proportion of

Medicaid payments affected by the

movement to managed care? An

important reason is that about 70% of

Medicaid expenditures goes to support

the health care of the disabled and for

long term care—neither of which is

included in state managed care

arrangements to any great extent.

Although research on the impact of

managed care is still relatively new,

studies of the public sector suggest that

costs savings can be achieved without

significant compromising quality. To

beleaguered states trying to find ways to

tame their Medicaid budget, the desire

to incorporate their disabled and long

term care populations under managed

care is understandable.