62864 Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices

Contact Person: Linda Martin (804)

737–6010.

Project Title: Texas—Achieving

Change for Texans.

Description: Statewide, would

implement requirement for a personal

responsibility agreement which

addresses issues such as child support

cooperation, early medical screening for

children, work requirements, drug and

alcohol abuse, school attendance, and

parenting skills training; would limit

the caretaker exemption from

employment services, disregard the

earned income and resources from

earnings of a child, set resource limits

which promote independence from

AFDC, eliminate work history and 100-

hour rules for otherwise eligible twoparent families. In Bexar County would

time-limit AFDC benefits to 12, 24, and

36 months depending on education and

job experience, with extensions of the

time-limit based on severe personal

hardship, or in cases where the State

could not provide supportive services,

or the where the local economy was in

such state that the recipient could not

reasonably be expected to find

employment, if State funds are available

to continue assistance. Transitional

Medicaid and child care services would

be provided to individuals who exhaust

their time-limited cash benefits. In two

metropolitan statistical areas establish

Individual Development Accounts to

promote the transition to independence

from AFDC, through allowable account

deductions for education, business startup costs and the like. In Fort Bend

County would allow at recipient option,

one-time AFDC cash emergency

assistance payments of $1,000 in lieu of

ongoing regular AFDC payments with

prohibition from applying for regular

AFDC for a period of 12 months from

date of receipt. In Dallas-Fort Worth

would require electronic imaging

(fingerprinting combined with

photographic identification).

Date Received: 10/6/95.

Title: AFDC/Medicaid.

Current Status: Pending.

Contact Person: Kent Gummerman,

(512) 438–3743.

Project Title: Utah—Untitled.

Description: Statewide, would

exclude the value of a vehicle for AFDC

recipient families, including those also

receiving Food Stamps. Would not

apply to initial eligibility determination.

Date Received: 10/3/95.

Type: AFDC.

Current Status: Pending.

Contact Person: Bill Biggs, (801) 538–

4337.

III. Listing of Approved Proposals since

November 1, 1995

None.

IV. Requests for Copies of a Proposal

Requests for copies of an AFDC or

combined AFDC/Medicaid proposal

should be directed to the

Administration for Children and

Families (ACF) at the address listed

above. Questions concerning the content

of a proposal should be directed to the

State contact listed for the proposal.

(Catalog of Federal Domestic Assistance

Program, No. 93562; Assistance Payments—

Research)

Dated: December 1, 1995.

Howard Rolston,

Director, Office of Planning, Research and

Evaluation.

[FR Doc. 95–29823 Filed 12–6–95; 8:45 am]

BILLING CODE 4184–01–P

Agency for Health Care Policy and

Research

Availability of Draft Clinical Practice

Guideline on Smoking Cessation for

Pre-Publication Review

AGENCY: Agency for Health Care Policy

and Research.

ACTION: Notice.

SUMMARY: The Agency for Health Care

Policy and Research (AHCPR)

announces the availability of a draft

AHCPR-sponsored clinical practice

guideline on smoking cessation for prepublication review. This guideline is

being produced by a multidisciplinary

private-sector panel of experts convened

by AHCPR. The expert panel will not

respond to individual comments but

will consider all comments in

determining revisions to the guideline.

Individuals interested in obtaining a

copy of the draft guideline for review

must agree not to disclose its content to

the public prior to its publication by

AHCPR.

DATES: Comments must be postmarked

by January 4, 1996.

SUPPLEMENTARY INFORMATION: The

Agency for Health Care Policy and

Research is responsible for the

development of clinical practice

guidelines that may be used by

physicians, other health care

practitioners, educators, and consumers

to assist in determining how diseases,

disorders, and other health conditions

can most effectively and appropriately

be prevented, diagnosed, treated, and

clinically managed. The AHCPR

facilitates the development of guidelines

by establishing private-sector panels

who are responsible for their content.

A private-sector panel of health care

experts and consumers was formed in

May, 1994 to develop a clinical practice

guideline to improve the effectiveness of

smoking cessation activities. A public

meeting was also held in November,

1994 for the panel to receive comments

and information relevant to

development of the guideline. The panel

has reviewed and synthesized the

literature on this topic and drafted a set

of conclusions and recommendations

based on the best available scientific

data and expert judgment.

A draft of these conclusions and

recommendations is now undergoing

peer review by a substantial number of

individuals and groups who are

knowledgeable about smoking cessation

programs and related activities. With

this notice, the panel and AHCPR are

also making the draft guideline available

to any person who wishes to review and

comment on it, so long as the person

agrees to honor the confidentiality of

this draft (as specified below).

After review of all comments

received, the panel will revise the draft

guideline and prepare the clinical

practice guideline on smoking cessation.

Potential reviewers should note that

AHCPR may disclose the names of the

guideline reviewers at the same time the

guideline is published. The AHCPR may

also release the review comments after

the guideline is published. However, the

comments will not be attributed to

specific reviewers.

Confidentiality Statement for Reviewers

During the review process, and until

published by AHCPR, the guideline is

confidential. It may not be quoted,

distributed, or copied without the prior

written consent of the panel chair.

All requests for the draft guideline

must include the following

confidentiality statement signed by the

requestor:

In order to protect the integrity of the

panel’s deliberative process and its final

product, I agree that: I will not release,

publicly present, publish, have published, or

otherwise disseminate any portion of the

draft Smoking Cessation guideline.

Signature llllllllllllllll

Date llllllllllllllllll

Affiliation lllllllllllllll

Name (printed or typed) lllllllll

Request for Draft Guideline

To receive a copy of the draft

guideline, requests must include:

Requestor’s name; Affiliation (business

or organization); Address (including zip

code); Telephone and Fax numbers;

Signed confidentiality statement; and

Information on reviewer’s computer

resources, if applicable, (needed to
Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices 62865

ascertain ability to use a computerized

program for guideline review).

Written requests, together with the

signed confidentiality statement, should

be mailed to: Cheryl Campbell, Panel

Manager; Technical Resources

International, Inc. (TRI), 3202 Tower

Oaks Boulevard, Rockville, Maryland

20852–4200. (Fax number: (301) 231–

6377.) If faxing the request, the original

signed confidentiality statement must

also be mailed.

Automated review process: A

computerized guideline review process,

supported by AHCPR, enables

comments to be entered on a specially

formatted diskette. A diskette will be

furnished, with instructions, to those

requesting the draft guideline. To

facilitate the review process, it is

recommended that reviewers use the

computer diskette to record their

comments. Reviewers who do not use a

diskette will be asked to provide

typewritten comments.

Requests for a copy of the draft

guideline should include the following

information regarding the computer

system to be used for reviewing the

guideline: Type of computer: IBM/

compatible or Macintosh; and if IBM/

compatible: the size of disk drive (3.5′′

or 5.25′′).

For technical assistance or questions

regarding computer resources, call the

Guideline Review Technical Support at

(301) 231–5250 ext. 100 and ask for Ms.

Cheryl Campbell.

FOR ADDITIONAL INFORMATION: Additional

information on the guideline

development process is contained in the

AHCPR Program Note, ‘‘Clinical

Practice Guideline Development,’’

(AHCPR Publication No. 93–0023) dated

August 1993.

This document may be obtained from

the AHCPR Publications Clearinghouse,

P.O. Box 8547, Silver Spring, MD 20907;

or call toll-free: 1–800–358–9295.

Dated: December 1, 1995.

Clifton R. Gaus,

Administrator.

[FR Doc. 95–29865 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–90–M

Food and Drug Administration

[Docket No. 95E–0300]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; CELLCEPT

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

CELLCEPT 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,

rm. 1–23, 12420 Parklawn Dr.,

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 CELLCEPT

(mycophenolate mofetil). CELLCEPT

is indicated for the prophylaxis of organ

rejection in patients receiving allogeneic

renal transplants. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for CELLCEPT (U.S. Patent

No. 4,753,935) from Syntex, 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

October 2, 1995, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the

approval of CELLCEPT 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

CELLCEPT is 2,479 days. Of this time,

2,304 days occurred during the testing

phase of the regulatory review period,

while 175 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: July 21, 1988. The

applicant claims June 24, 1988, as the

date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was July 21, 1988,

which was 30 days after FDA receipt of

IND 31,747 on June 21, 1988.

2. The date the application was

initially submitted with respect to the

human drug product under section 507

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 357): November 10, 1994.

FDA has verified the applicant’s claim

that the new drug application (NDA) for

CELLCEPT (NDA 50–722) was initially

submitted on November 10, 1994.

3. The date the application was

approved: May 3, 1995. FDA has

verified the applicant’s claim that NDA

50–722 was approved on May 3, 1995.

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 824 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before February 5, 1996, 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 June 5, 1996, for a

determination regarding whether the