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
6550 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product ULTIVATM

(remifentanil hydrochloride).

ULTIVATM is indicated for intravenous

administration as follows: (1) As an

analgesic agent for use during the

induction and maintenance of general

anesthesia for inpatient and outpatient

procedures, and for continuation as an

analgesic into the immediate

postoperative period under the direct

supervision of an anesthesia practitioner

in a postoperative anesthesia care unit

or intensive care setting; and (2) as an

analgesic component of monitored

anesthesia care. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for ULTIVATM (U.S. Patent

No. 5,019,583) from Glaxo Wellcome,

Inc., and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

November 4, 1996, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of ULTIVATM represented the

first permitted commercial marketing or

use of the product. Shortly thereafter,

the Patent and Trademark Office

requested that FDA determine the

product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for

ULTIVATM is 2,222 days. Of this time,

1,920 days occurred during the testing

phase of the regulatory review period,

while 302 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: June 14, 1990. FDA

has verified the applicant’s claim that

the date that the investigational new

drug application became effective was

on June 14, 1990.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: September 15, 1995. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

ULTIVATM (NDA 20–630) was initially

submitted on September 15, 1995.

3. The date the human drug was

approved: July 12, 1996. FDA has

verified the applicant’s claim that NDA

20–630 was approved on July 12, 1996.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,088 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before April 14, 1997, submit to

the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before May 5, 1997, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

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

Friday.

Dated: January 31, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–3417 Filed 2–11–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[Document Identifier: HCFA–9026]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS. In compliance

with the Paperwork Reduction Act of

1995 (44 U.S.C. 3501 et seq.), 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 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.

HCFA–9026 Type of Information

Collection Request: Reinstatement,

without change, of previously approved

collection for which approval has

expired; Title of Information Collection:

Intermediary Request to Hospitals for

Medical Information on Inpatient

Claims for Statutorily Excluded

Services/SSA 1862; 42 CFR 411.15; FR

Vol. 60, No. 181; Form No.: HCFA–

9026; Use: This information request is to

enable intermediaries to obtain hospital

medical records for inpatient claims

involving statutorily excluded services

and other non-covered services and

devices. 42 CFR 411.15 is the regulation

supporting this collection of

information; Frequency: On occasion;

Affected Public: Business or other for

profit, not for profit institutions, State,

local, or tribal governments, Federal

government; Number of Respondents:

5,258; Total Annual Responses: 20,355;

Total Annual Hours: 5,088.

To obtain copies of 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 should be sent

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: February 3, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–3498 Filed 2–11–97; 8:45 am]

BILLING CODE 4120–03–P