6546 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or the U.S. Postal Service. Private

metered postmarks will not be

acceptable as proof of timely mailing.)

2. Late Applications:

Applications that do not meet the

criteria in 1.a. or 1.b. above are

considered late applications. Late

applications will not be considered in

the current competition and will be

returned to the applicant.

Where To Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and telephone number and will

need to reference to Announcement 716.

You will receive a complete program

description, information on application

procedures, and applications forms.

If you have questions after reviewing

the contents of all the documents,

business management business

management technical assistance may

be obtained from Joanne Wojcik, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Mailstop E–13,

Atlanta, GA 30305, telephone (404)

842–6535 or internet address

<jcw6@cdc.gov>.

Programmatic technical assistance

may be obtained from David J.

Thurman, M.D., M.P.H., Division of

Acute Care, Rehabilitation Research,

and Disability Prevention, National

Center for Injury Prevention and

Control, Centers for Disease Control and

Prevention (CDC), 4770 Buford

Highway, NE., Mailstop F–41, Atlanta,

GA 30341–3724, telephone (770) 488–

4031 or internet address

<dxt9@cdc.gov>.

This and other CDC announcements

are available through the CDC homepage

on the Internet. The address for the CDC

homepage is <http://www.cdc.gov>.

CDC will not send application kits by

facsimile or express mail.

Please refer to Announcement 716

when requesting information and

submitting an application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the ‘‘INTRODUCTION’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: February 6, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

Traumatic Brain Injury Surveillance

References

Methods and Key Resources

Thurman DJ, Sniezek JE, Johnson D,

Greenspan A, Smith SM. Guidelines

for Surveillance of Central Nervous

System Injury. Atlanta: Centers for

Disease Control and Prevention, 1995.

Klaucke DN, Buehler JW, Thacker SB, et

al. Guidelines for evaluating

surveillance systems. MMWR

1988;37(s-5):1–18.

Health Care Financing Administration.

International Classification of

Diseases, 9th Revision, Clinical

Modification, Third Edition.

Washington, DC: U.S. Department of

Health and Human Services, 1989.

Epidemiologic Studies and Reviews

Kraus, JF. Epidemiology of head injury.

In Cooper, PR, ed., Head Injury, Third

Edition. Baltimore: Williams and

Wilkins, 1993; 1–25.

Sosin DM, Sniezek JE, Waxweiler RJ.

Trends in death associated with

traumatic brain injury, 1979 through

1992. JAMA 1995; 273:1778.

Published epidemiologic studies of

TBI are also reviewed in the article

‘‘Epidemiology of Traumatic Brain

Injury in the United States’’ located at

the Internet website of the National

Center for Injury Prevention and Control

<http://www.cdc.gov/ncipc/dacrrdp/

tbi.htm>.

Centers for Disease Control and

Prevention. Traumatic Brain Injury—

Colorado, Missouri, Oklahoma, and

Utah, 1990–93. MMWR 1997; 46(1):8–

11.

How to Obtain a Copy of the CDC

Guidelines for Surveillance of Central

Nervous System Injury:

A copy of these Guidelines can be

obtained either by calling 770–488–

4031, by submitting the ‘‘NCIPC

Publications Order Form’’ through the

Internet website of the National

Center for Injury Prevention and

Control <http://www.cdc.gov/ncipc/

pub-res/pubsav.htm>, or by writing to

the Division of Acute Care,

Rehabilitation Research, and Disability

Prevention, National Center for Injury

Prevention and Control, Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mailstop F–

41, Atlanta, GA 30341–3724.

[FR Doc. 97–3473 Filed 2–11–97; 8:45 am]

BILLING CODE 4163–18–P

Administration for Children and

Families

Children’s Bureau/National Center on

Child Abuse and Neglect Proposed

Research Priorities for Fiscal Years

1997–2001

AGENCY: Administration on Children,

Youth and Families (ACYF),

Administration for Children and

Families (ACF), HHS.

ACTION: Notice of proposed child abuse

and neglect research priorities for fiscal

years 1997–2001.

SUMMARY: The National Center on Child

Abuse and Neglect/Children’s Bureau

(NCCAN/CB) within the Administration

on Children, Youth and Families

(ACYF) announces the proposed

priorities for research on the causes,

prevention, assessment, identification,

treatment, cultural and socio-economic

distinctions, and the consequences of

child abuse and neglect.

NOTE: The National Center on Child

Abuse and Neglect (NCCAN) was

established in 1974 to carry out the

functions of the Child Abuse Prevention

and Treatment Act (CAPTA). Pursuant

to Pub. L. 104–235, the Child Abuse

Prevention and Treatment Act

Amendments of 1996, the Office on

Child Abuse and Neglect (OCAN) will,

in the near future, be established by the

Secretary for the purpose of

coordinating the functions and activities

of CAPTA, replacing NCCAN.

Section 104(a)(2) of CAPTA, as

amended by Pub. L. 104–235, requires

the Secretary to publish proposed

priorities for research activities for

public comment and allow 60 days for

public comment on such proposed

priorities. The proposed priorities are

being announced for the five year period

that corresponds to the authorization

period for CAPTA. Because the amount

of Federal funds available for

discretionary activities in Fiscal Years

1997–2001 is expected to be limited,

respondents are encouraged to

recommend how the proposed issues

should be prioritized.

As research issues arise or new issues

emerge through consultation with other

entities, additional announcements of

proposed priorities will be published for

public comment.

The actual solicitation of grant

applications will be published

separately in the Federal Register for
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices 6547

each fiscal year. Solicitations for

contracts will be announced, at later

dates, in the Commerce Business Daily.

No proposals, concept papers, or other

forms of application should be

submitted at this time.

No acknowledgment will be made of

the comments submitted in response to

this notice, but all comments received

by the deadline will be reviewed and

given thoughtful consideration in the

preparation of the final funding

priorities for the announcements. The

names and addresses of all those who

submit comments will be added to the

mailing list for receiving copies of the

final program announcements when

they are published.

DATES: In order to be considered,

comments must be received no later

than April 14, 1997.

ADDRESSES: Comments should be sent

to: James A. Harrell, Deputy

Commissioner, Administration on

Children, Youth and Families,

Attention: CB/NCCAN, PO Box 1182,

Washington, DC. 20013.

Electronic comments may be sent to:

<comments@acf.dhhs.gov>

If you comment electronically and

wish to be added to the mailing list,

please include a street address.

SUPPLEMENTARY INFORMATION:

I. Background

In addition to projects funded under

priority areas selected as a result of this

announcement, NCCAN/CB may

continue discretionary funding for:

• The National Clearinghouse on

Child Abuse and Neglect Information;

• The National Resource Center on

Child Maltreatment;

• Future phases of the Consortium for

Longitudinal Studies of Child

Maltreatment;

• The National Data Archive on Child

Abuse and Neglect; and

• The National Child Abuse and

Neglect Data System (NCANDS)

technical assistance and technical

support program.

NCCAN/CB will continue to pursue

Interagency Agreements to develop

collaborative research with other

Federal agencies to carry out an

interdisciplinary program of research

that is designed to provide information

needed to better protect children from

abuse or neglect and to improve the

well-being of abused or neglected

children. NCCAN/CB also will continue

to participate in the development of a

Federal framework for child welfare

research and an ACF strategic research

agenda on child abuse and neglect.

In addition, NCCAN/CB explicitly

acknowledges on-going analytic work

with the National Incidence Study

(NIS), the National Child Abuse and

Neglect Data System (NCANDS), and the

Adoption and Foster Care Analysis and

Reporting System (AFCARS) data

collection projects that will inform

several of the topics described below.

Comments about research topics and

future activities should be addressed in

light of this ongoing work. The relevant

topics include: recurrence (the numbers

and characteristics of children and

families in both substantiated and

unsubstantiated reports that return to

the system) and patterns of recurrence

(repeat substantiations, as well as

unsubstantiated cases that return as

substantiated cases) which will be

topics of analysis in the NCANDS

Detailed Case Data Component (DCDC)

in the coming year; the removal of

children and abuse and neglect in foster

care will be examined by cross-walking

data between NCANDS and AFCARS;

mandated reporter characteristics and

child characteristics, as correlates, will

be explored through further analysis of

both NCANDS and NIS data; and court

activity related to substantiated

reporting will be explored through

additional analyses of NCANDS data.

Information on these and other prior

and continuing projects supported by

NCCAN/CB as well as on other studies

of child maltreatment are available

through the National Clearinghouse on

Child Abuse and Neglect Information,

PO Box 1182, Washington, DC. 20013

(1–800–394–3366).

The proposed research priority areas

which follow have been developed in

consultation with several entities and

from several sources.

• The 1996 reauthorization of

CAPTA, section 104.

• The National Research Council

(NRC), Commission on Behavioral and

Social Sciences and Education

(CBASSE), Panel on Research on Child

Abuse and Neglect report,

Understanding Child Abuse and

Neglect. This report was produced by

CBASSE in response to a request from

ACYF to undertake a comprehensive

review and synthesis of research on

child abuse and neglect and to

recommend research needs and

priorities for the remainder of the

decade. Over the last several years,

NCCAN/CB has responded to individual

recommendations as funding allowed.

NCCAN/CB will continue to address the

concerns raised in the NRC report, as

appropriate.

• Reviews of current literature on

child abuse and neglect.

• Findings from recently completed

studies.

• Recommendations from the field.

• Meetings with other Departmental

units and professional organizations.

NCCAN/CB will continue to examine

the recommendations from these

various sources in light of other ongoing

efforts and the applicability of the

recommendations to Federal research

goals.

II. Proposed Child Abuse and Neglect

Research Priorities for Fiscal Years

1997–2001

A. Legislative Topics:

A number of research topics are

suggested in the 1996 reauthorization of

CAPTA, section 104. Comments are

requested on the feasibility of these

topics for research, their pertinence to

the field, and their likelihood to

promote innovative research that

increases our understanding of all

aspects of child maltreatment.

The Research Frame: In general, all

NCCAN/CB sponsored research must fit

within an overall frame of research on

the nature and scope of child abuse and

neglect; the causes, prevention,

assessment, identification, treatment,

cultural and socio-economic

distinctions, and consequences of child

abuse and neglect; appropriate, effective

and culturally sensitive investigative,

administrative, and judicial procedures

with respect to cases of child abuse; and

the national incidence of child abuse

and neglect. These areas of inquiry

underlie all other questions and apply

especially to inquiries that are

investigator-initiated, as described

below in section C.

Mandated Reporting: Because entry

into the child protective services system

may be affected by factors in addition to

those specific to an incident, research

which explores these other factors will

elucidate the entry, service, re-entry,

and flow processes experienced by

children and their families. Mandated

reporting, for example, affects the

number of reports made, the gateways

into child protective services, and the

allocation of resources in relation to the

number of reports accepted for

investigation.

State child protective services (CPS)

data show significant differences in the

reporting patterns and substantiation

rates for different reporting sources. For

instance in an analysis of all reports

investigated by CPS in 10 States in

1993, it was found that 60 percent of

reports from legal and law enforcement

professionals were substantiated or

indicated versus 45 percent of reports

from educators. (Child Abuse and

Neglect Case Level Data 1993: Working

Paper 1).
6548 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

Questions about mandated reporting

include those that explore the extent to

which the lack of adequate resources

and the lack of adequate training of

individuals required by law to report

suspected cases of child abuse have

contributed to the inability of a State to

respond effectively to serious cases of

child abuse and neglect.

Unsubstantiated, unfounded, and

false reports: Unsubstantiated,

unfounded, and falsely reported cases of

child abuse and neglect put

considerable stress on the children and

families who are the subjects of the

reports, but also put stresses on the

child protective service system itself. At

this time, we have very little knowledge

of the relationship between reports,

however false, unsubstantiated or

unfounded, and future maltreatment

and system entry. Research questions

might inquire about: the extent to which

the number of unsubstantiated,

unfounded, and falsely reported cases of

child abuse or neglect contribute to the

inability of a child welfare system or

child protective services system to

respond effectively to serious cases of

child abuse or neglect; the extent to

which and the pathways by which

unsubstantiated reports return as more

serious cases of child abuse or neglect.

Reports in the context of family court

proceedings: Some reports occur in a

context of divorce, custody or other

family court proceedings. NCCAN/CB is

interested in the interaction between

this venue and the child protective

services system. Research might be at

the individual, case, or system level.

Questions might include: How does

family history with a child protective

services system relate to family court

proceedings? Does entry into the child

protective services system via the family

court gateway have a relationship to

particular case outcomes? What is the

relationship, if any, between

unsubstantiated, unfounded, and false

reports and families involved in

divorce, custody, or other family court

actions?

Substitute care: NCCAN/CB is

interested in the relationship between

child protective service systems and

other child welfare programs as well as

a more detailed look at differentiated

effects within substitute care

experiences. Research interests include:

What is the context, incidence, and

prevalence of child physical, sexual,

and emotional abuse and physical and

emotional neglect occurring in

substitute care? Because substitute care

is itself a service, are children in

substitute care referred for and receiving

additional services related to the

precipitating incident or additional

incidents of abuse and neglect? What is

the efficacy of those additional services

in terms of safety, permanency, and

child well-being outcomes and does

efficacy have a relationship to either the

type of abuse precipitating the

placement, demographic characteristics

of the child (e.g., age, sex, disability), or

characteristics of the substitute

placement (e.g., relative care, licensing,

certification).

Substantiated cases: Substantiated

cases of child maltreatment represent a

particular sector of the child protective

service population. NCCAN/CB is

interested in funding research that

explores system and sequelae questions

with substantiated case samples, which

may answer such questions as: Can

‘‘system history’’ and ‘‘client

characteristics’’ be used to make

predictions about future service needs

and system usage? What are the number

and characteristics of substantiated

cases that result in a judicial finding of

child abuse or neglect or related

criminal court convictions?

B. Other Topics

Child Safety and Child Fatality:

NCCAN/CB is interested in research that

explores ways to understand the nature

and scope of child abuse and neglect

that results in fatalities or permanent

disabilities and systemic responses to

child fatalities. Questions might include

those which would explore reducing

fatalities by asking questions about

efficacious placement of siblings or

termination of parental rights (TPR), as

well as more prevention-oriented

questions, including those which

explore the context of home and

community environments related

especially to other forms of violence and

the availability of a continuum of

comprehensive community preventive

and treatment services. Other research

interests include: explorations of the

relationship of child fatality or serious

injuries to placement and TPR

decisions; and ‘‘best practices’’ and

model development for safety

assessment. Recommendations are

requested on the ability to sustain a

research focus on, and the usefulness of

a focus on, variables related to

strengths-based programming and

resiliency characteristics at the family

level especially as they are related to

placement and TPR.

Co-occurrence: Suggestions for

additional research questions as well as

comments are sought on research

exploring the nature of the pathways

between the co-occurrence of child

maltreatment and substance abuse and/

or domestic violence as those pathways

relate to the prevention of child

maltreatment, assessment of cooccurrence, treatment or intervention,

and system responses to co-occurrence

(including demands on treatment,

training, and resources). Preliminary

questions might include: What are the

variety of system responses to

identifying, as a dynamic issue, and

coordinating, as a structural issue,

services for co-occurrence? Do treatment

models which begin with one or the

other symptom have more efficacious

outcomes? Are there identifiable ‘‘best

practices’’ for treatment or service?

Definitions: In the interest of

supporting on-going work and

encouraging new work in creating a

consensus on definitions for research

purposes, NCCAN/CB seeks

recommendations for field tests in

research settings and other applications

of a set of working data elements

developed by the research committee of

the Interagency Task Force on Child

Abuse and Neglect. The committee has

been working with researchers over the

past three years to identify the data

elements that represent a core of

consensus for research purposes about

the experiences of child abuse and

neglect. The overall goal of the work of

the committee has been to present a

common data collection set of attributes

that explicitly describe the nature of

maltreatment in a particular sample and

allows samples to be compared, in terms

of maltreatment experiences, across

studies.

Graduate Student Research

Fellowships: With a continuing interest

in encouraging new investigators to

select child maltreatment as an area of

specialty, NCCAN/CB seeks comments

comparing the two models of graduate

student research support employed

most recently. One model awarded

funds directly to eligible institutions for

specific eligible individual students.

The second model awarded funds to

eligible institutions for a group

consisting of a faculty member and

eligible students, or student. The goal of

the Fellowships is to develop

mechanisms which support the renewal

of the research field by increasing the

number of new researchers who elect to

study child abuse and neglect.

Outcomes: Building on the work of

the Children’s Bureau regarding

monitoring by outcomes and thinking

ahead to the requirements for outcomebased performance partnerships,

NCCAN/CB seeks comments on the

socio-economic, cultural, and

community variances which have

bearing on the use of ‘‘safety,’’

‘‘permanency,’’ and ‘‘child and family

well-being’’ as outcomes, and tools for

assessing the outcomes. Questions
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices 6549

might include: What is the relationship

between the availability of tools for

assessing particular outcomes and a

community’s efforts to achieve those

outcomes? From a systemic perspective,

how does the definition of outcomes, or

the operationalization of them, have

impact on the system’s delivery of

services and the success of particular

populations achieving the outcomes?

Over-represented populations and

special populations (i.e., racial and

ethnic groups, children with

disabilities): With continuing concern

about over-representation, research

questions might include: What are the

characteristics of the system or the

context that may contribute to the overrepresentation of some populations in

child protective service caseloads? How

do systems achieve a better

understanding of the dynamics of the

communities that are over-represented?

How are clients assessed in order to

generate knowledge about these

populations that is formed from

appropriate cultural and sociological

perspectives?

NCCAN/CB is interested in the safety

and well-being of immigrant children

and their families, as a special

population. Questions might include

explorations of service utilization,

outreach, and cultural context. More

specific examples of research questions

might include: What are the

relationships between child safety and

well-being, child protective services, the

characteristics and needs of the children

and families themselves, and the

communities in which they reside? How

are the needs of immigrant children and

their families identified and assessed?

What are effective maltreatment

prevention and treatment program

models for these populations?

Secondary Analysis: NCCAN/CB

seeks comments regarding the interest of

the field for funding of secondary

analyses of federally-financed data

collections and existing datasets.

Opportunities here exist in the analysis

of, for example, Head Start data, data

from the Adoption Foster Care Analysis

and Reporting System (AFCARS), the

1994 National Study of Protective,

Preventive and Reunification Services

Delivered to Children and their

Families, the National Child Abuse and

Neglect Data System (NCANDS), and the

National Incidence Study (NIS),

regarding specific field-generated or

federally-generated research inquiries

related to child maltreatment.

Comments should include (1)

suggestions for minimal award sizes and

(2) suggestions for application strategies

that reduce the burden of applying for

these small-amount grants.

Triage: Triage, here, is used to

describe a differentiated response

service-entry or resource allocation

model for handling child abuse and

neglect reports. Some triage models

include assignment to service prior to

investigation for some classes of reports.

Research interests include questions

about: The effects of a triage process on

child safety and child and family wellbeing, caseload sizes, and resource

allocation; and evaluations of the

impact and efficacy of criteria, tools,

and protocols for case assignment,

safety and risk assessment. Does a triage

approach result in changes in system

responses, client behavior (i.e.,

recidivism), changes in public

perception of CPS, or changes in clients’

perceptions of CPS responsiveness to

their needs or to the perception of a

punitive nature of CPS service?

Welfare Reform and System Changes:

The impact of recent changes in family

support entitlements, block granting of

welfare funds, work requirements, child

care needs, and other systemic changes

is unknown. NCCAN/CB is interested in

research which explores the interactions

of these changes in welfare policy at the

state and local level with child safety in

general and the protective needs of

children in particular. States have a

range of options available to them as

they implement new welfare programs.

Questions might include: How do these

policy choices affect child protective

services agencies’ ability to protect

children? What are the impacts on case

loads, case characteristics, and system

entry and exit, for example, of family

caps, time limits, and the transition to

work?

C. Field Initiated Research on Child

Abuse and Neglect

The generation of new knowledge for

understanding critical issues in child

abuse and neglect improves prevention,

identification, assessment, and

treatment. Research areas to be

addressed may be those that will

expand the current knowledge base,

build on prior research, contribute to

practice enhancements, inform policy,

improve science, and provide insights

into new approaches to the assessment,

prevention, intervention, and treatment

of child maltreatment (i.e., physical

abuse, sexual abuse, emotional

maltreatment, or neglect) on any of the

topics listed in (A) Legislative Topics,

(B) Other Topics, above, or any other

child maltreatment topic.

In addition to the topics cited above,

practitioners and researchers are

encouraged to propose other relevant

subjects for research topics.

(Catalog of Federal Domestic Assistance

Program Number 93.670, Child Abuse and

Neglect Prevention and Treatment)

Dated: February 7, 1997.

James A. Harrell,

Deputy Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 97–3469 Filed 2–11–97; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

[Docket No. 96E–0385]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; ULTIVATM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

ULTIVATM and is publishing this notice

of that determination as required by

law. FDA has made the determination

because of the submission of an

application to the Commissioner of

Patents and Trademarks, Department of

Commerce, for the extension of a patent

which claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts