Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices 16161

Promotion, Office of Public Health and

Science, Office of the Secretary.

At its first meeting, the membership

will establish procedures for conducting

the business of the Council and for

reporting the results of its meetings to

the Secretary. Other items on the agenda

include consideration of reports from

Healthy People 2000 Consortium focus

groups, discussion of data developments

relevant to Healthy People 2010, and

strategies for engaging the business

community in the Department’s

prevention efforts. During its tenure, the

Council will oversee the development of

Healthy People 2010, the third

generation of a national initiative to

prevent disease and promote the health

of the American people. It is anticipated

that a call for submission by the public

of health promotion/disease prevention

objectives for 2010 will be published in

the fall of 1997. At a second meeting

proposed for spring of 1998, the Council

will consider the resulting submissions

as the basis for a draft of the 2010

objectives to be published in the fall of

1998.

If time permits at the conclusion of

the formal agenda of the Council, the

Chair may allow brief oral statements

from interested parties and persons in

attendance. The meeting is open to the

public; however, seating is limited. If

you will require a sign language

interpreter, please call Gloria Robledo

(202) 401–7736 by 4:30 p.m. E.S.T on

April 7, 1997.

Dated: March 27, 1997.

Susanne A. Stoiber,

Acting Deputy Assistant Secretary for Health

(Disease Prevention and Health Promotion).

[FR Doc. 97–8598 Filed 4–3–97; 8:45 am]

BILLING CODE 4160–17–M

Notice of a Meeting of the National

Bioethics Advisory Commission

(NBAC); Human Subjects

Subcommittee

On Saturday, April 12, 1997, in

conjunction with National Bioethics

Advisory Commission’s April 13

meeting, the Human Subjects

Subcommittee is now scheduled to meet

from 2:00 to 5:00 p.m. at the Crystal City

Marriott, Salon E, Jefferson Davis

Highway, Arlington, VA. 22202. The

meeting is open to the public. For

public statements, please contact the

person listed below.

For Further Information Contact: Ms.

Henrietta D. Hyatt-Knorr, National

Bioethics Advisory Commission, MSC–

7508, 6100 Executive Boulevard, Suite

3C01, Rockville, Maryland 20892–7508,

telephone 301–402–4242, fax number

301–480–6900.

Dated: March 31, 1997.

Henrietta D. Hyatt-Knorr,

Deputy Executive Director (Acting), National

Bioethics Advisory Commission.

[FR Doc. 97–8596 Filed 4–3–97; 8:45 am]

BILLING CODE 4160–17–P

National Committee on Vital and Health

Statistics; Meetings

Pursuant to the Federal Advisory

Committee Act, the Department of

Health and Human Services announces

the following advisory committee

meetings.

Name: National Committee on Vital and

Health Statistics (NCVHS), Subcommittee on

Health Data Needs, Standards, and Security.

Times and Dates: 9:30 a.m.–6 p.m., April

15, 1997; 9 a.m.–5:30 p.m., April 16, 1997.

Place: Room 503A, Hubert H. Humphrey

Building, 200 Independence Avenue, SW,

Washington, DC 20201.

Status: Open.

Purpose: Under the Administrative

Simplification provisions of Pub. L. 104–191,

the Health Insurance Portability and

Accountability Act of 1996 (HIPAA), the

Secretary of Health and Human Services is

required to adopt standards for specified

transactions to enable health information to

be exchanged electronically. The law

requires that, within 24 months of adoption,

all health plans, health care clearinghouses,

and health care providers who choose to

conduct these transactions electronically

must comply with these standards. The law

also requires the Secretary to adopt a number

of supporting standards including standards

for code sets and classifications systems. The

Secretary is required to consult with the

National Committee on Vital and Health

Statistics (NCVHS) in complying with these

provisions. The NCVHS is the Department’s

federal advisory committee on health data,

privacy and health information policy.

To assist in the development of the NCVHS

recommendations to HHS, the NCVHS

Subcommittee on Health Data Needs,

Standards, and Security has been holding a

series of public meetings to obtain the views,

perspectives and concerns of interested and

affected parties. On the morning of April 15,

the Subcommittee’s Working Group on Data

Standards and Security will hold a public

meeting at which they will be briefed by HHS

on the status of and plans for unique

identifiers for providers and payers.

On the afternoon of April 15th and all day

on April 16th, the full Subcommittee will

consider and discuss perspectives on medical

and clinical coding and classification issues

in the implementation of Pub. L. 104–191.

For the meeting, the Subcommittee is

inviting specific organizations representing

both the users and developers of medical and

clinical classification systems to address the

following questions in writing, to make brief

oral presentations of their answers, and to

answer further questions from the

Subcommittee. Other organizations that

would also like to submit written statements

on these issues are invited to do so.

Questions to be Addressed:

1. What medical/clinical codes and

classifications do you use in administrative

transactions now? What do you perceive as

the main strengths and weaknesses of current

methods for coding and classification of

encounter and/or enrollment data?

2. What medical/clinical codes and

classifications do you recommend as initial

standards for administrative transactions,

given the time frames in the HIPAA? What

specific suggestions would you like to see

implemented regarding coding and

classification?

3. Prior to the passage of HIPAA, the

National Center for Health Statistics initiated

development of a clinical modification of

ICD–10 (ICD–10–CM) and the Health Care

Financing Administration undertook

development of a new procedure coding

system for inpatient procedures (called ICD–

10–PCS), with a plan to implement them

simultaneously in the year 2000. On the preHIPAA schedule, they will be released to the

field for evaluation and testing by 1998. If

some version of ICD is to be used for

administrative transactions, do you think it

should be ICD–9–CM or ICD–10–CM and

ICD–10–PCS, assuming that field evaluations

are generally positive?

4. Recognizing that the goal of Pub. L. 104–

191 is administrative simplification, how,

from your perspective, would you deal with

the current coding environment to improve

simplification and reduce administrative

burden, but also obtain medically meaningful

information?

5. How should the ongoing maintenance of

medical/clinical code sets and the

responsibility, intellectual input and funding

for maintenance be addressed for the

classification systems included in the

standards? What are the arguments for having

these systems in the public domain versus in

the private sector, with or without copyright?

6. What would the resource implications

be of changing from the coding and

classification systems that you currently are

using in administrative transactions to other

systems?

7. A Coding and Classification

Implementation Team has been established

within the Department of Health and Human

Services to address the requirements of Pub.

L. 104–191. Does your organization have any

concerns about the process being undertaken

by the Department to carry out the

requirements of the law in regard to coding

and classification issues? If so, what are those

concerns and what suggestions do you have

for improvements?

Notice: In the interest of security, the

Department has instituted stringent

procedures for entrance to the Hubert H.

Humphrey building by non-government

employees. Thus, persons without a

government identification card will need to

have the guard call for an escort to the

meeting.

Contact Person for More Information:

Substantive program information as well as

summaries of the meeting and a roster of

committee members may be obtained from

James Scanlon, NCVHS Executive Staff
16162 Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices

Director, Office of the Assistant Secretary for

Planning and Evaluation, DHHS, Room 440–

D, Humphrey Building, 200 Independence

Avenue SW., Washington, DC 20201,

telephone (202) 690–7100, or Marjorie S.

Greenberg, Acting Executive Secretary,

NCVHS, NCHS, CDC, Room 1100,

Presidential Building, 6525 Belcrest Road,

Hyattsville, Maryland 20782, telephone (301)

436–7050. Information also is available on

the NCVHS home page of the HHS website:

http://aspe.os.dhhs.gov/ncvhs.

Dated: March 26, 1997.

James Scanlon,

Director, Division of Data Policy, Office of

the Assistant Secretary for Planning and

Evaluation.

[FR Doc. 97–8597 Filed 4–3–97; 8:45 am]

BILLING CODE 4151–04–M

Centers for Disease Control and

Prevention

[30 DAY–3–97]

Agency Forms Undergoing Paperwork

Reduction Act Review

The Centers for Disease Control and

Prevention (CDC) publishes a list of

information collection requests under

review by the Office of Management and

Budget (OMB) in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Office on (404) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Project

1. Congenital Syphilis Case

Investigation and Report Form (CDC

73.126 REV 09–91)–(0920–0128). This

request is for a 3-year extension of

clearance. Reducing congenital syphilis

(CS) is a national objective in the DHHS

Report entitled Healthy People 2000:

Midcourse Review and 1995 Revisions.

Objective 19.4 of this document states

the goal: ‘‘reduce congenital syphilis to

an incidence of no more than 40 cases

per 100,000 live births’’ by the year

2000. In order to meet this national

objective, an effective surveillance

system for CS must be continued in

order to monitor current levels of

disease and progress towards the year

2000 objective. This data will also be

used to develop intervention strategies

and to evaluate ongoing control efforts.

The total annual burden hours are 500.

Respondents

Number

of respondents

Number

of responses/

respondent (in

hrs.)

Average

burden/

response

(in hrs.)

State and

local

health department .. 2000 1 0.25

Dated: March 28, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–8618 Filed 4–3–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 96E–0503]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; XALATANTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

XALATANTM 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

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 XALATANTM

(latanoprost). XALATANTM is indicated

for the reduction of elevated intraocular

pressure in patents with open-angle

glaucoma and ocular hypertension who

are intolerant of other intraocular

pressure lowering medications or

insufficiently responsive (failed to

achieve target IOP determined after

multiple measurements over time) to

another intraocular pressure lowering

medication. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for XALATANTM (U.S.

Patent No. 4,599,353) from the Trustees

of Columbia University in the City of

New York, and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated February 18, 1997, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of XALATANTM

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

XALATANTM is 1,875 days. Of this

time, 1,519 days occurred during the

testing phase of the regulatory review

period, while 356 days occurred during

the approval phase. These periods of

time were derived from the following

dates: