20104 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Notices

Attachment D—Certification Regarding

Debarment, Suspension, and Other

Responsibility Matters-Primary Covered

Transactions

By signing and submitting this proposal,

the applicant, defined as the primary

participant in accordance with 45 CFR Part

76, certifies to the best of its knowledge and

believe that it and its principals:

(a) are not presently debarred, suspended,

proposed for debarment, declared ineligible,

or voluntarily excluded from covered

transactions by any Federal Department or

agency;

(b) have not within a 3-year period

preceding this proposal been convicted of or

had a civil judgment rendered against them

for commission of fraud or a criminal offense

in connection with obtaining, attempting to

obtain, or performing a public (Federal, State,

or local) transaction or contract under a

public transaction; violation of Federal or

State antitrust statutes or commission of

embezzlement, theft, forgery, bribery,

falsification or destruction of records, making

false statements, or receiving stolen property;

(c) are not presently indicted or otherwise

criminally or civilly charged by a

governmental entity (Federal, State or local)

with commission of any of the offenses

enumerated in paragraph (1)(b) of this

certification; and

(d) have not within a 3-year period

preceding this application/proposal had one

or more public transactions (Federal, State, or

local) terminated for cause or default.

The inability of a person to provide the

certification required above will not

necessarily result in denial of participation in

this covered transaction. If necessary, the

prospective participant shall submit an

explanation of why it cannot provide the

certification. The certification or explanation

will be considered in connection with the

Department of Health and Human Services

(HHS) determination whether to enter into

this transaction. However, failure of the

prospective primary participant to furnish a

certification or an explanation shall

disqualify such person from participation in

this transaction.

The prospective primary participant agrees

that by submitting this proposal, it will

include the clause entitled ‘‘Certification

Regarding Debarment, Suspension,

Ineligibility, and Voluntary Exclusion-Lower

Tier Covered Transaction. ‘‘provided below

without modification in all lower tier

covered transactions and in all solicitations

for lower tier covered transactions.

Certificaiton Regarding Debarment,

Suspension, Ineligibility and Voluntary

Exclusion-Lower Tier Covered Transactions

(To Be Supplied to Lower Tier Participants)

By signing and submitting this lower tier

proposal, the prospective lower tier

participant, as defined in 45 CFR Part 76,

certifies to the best of its knowledge and

belief that it and its principals:

(a) are not presently debarred, suspended,

proposed for debarment, declared ineligible,

or voluntarily excluded from participation in

this transaction by any federal department or

agency.

(b) where the prospective lower tier

participant is unable to certify to any of the

above, such prospective participant shall

attach an explanation to this proposal.

The prospective lower tier participant

further agrees by submitting this proposal

that it will include this clause entitled

‘‘certification Regarding Debarment,

Suspension, Ineligibility, Voluntary

Exclusion-Lower Tier Covered Transactions.

‘‘without modification in all lower tier

covered transactions and in all solicitations

for lower tier covered transactions.

Attachment E—Certification Regarding

Environmental Tobacco Smoke

Public Law 103–227, Part C-Environmental

Tobacco Smoke, also known as the ProChildren Act of 1994 (Act), requires that

smoking not be permitted in any portion of

any indoor facility owned or leased or

contracted for by an entity and used

routinely or regularly for the provision of

health, day care, education, or library

services to children under the age of 18, if

the services are funded by Federal programs

either directly or through State or local

governments, by Federal grant, contract, loan,

or loan guarantee.The law does not apply to

children’s services provided in private

residences, facilities funded solely by

Medicare or Medicaid funds, and portions of

facilities used for inpatient drug or alcohol

treatment. Failure to comply with the

provisions of the law may result in the

imposition of an administrative compliance

order on the responsible entity.

By signing and submitting this application

the applicant/grantee certifies that it will

comply with the requirements of the Act. The

applicant/grantee further agrees that it will

require the language of this certification be

included in any subawards which contain

provisions for children’s services and that all

subgrantees shall certify accordingly.

[FR Doc. 95–10029 Filed 4–21–95; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

Request for Nominations for Members

on Public Advisory Committees; Food

Advisory Committee

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for members to serve on

the Food Advisory Committee (the

Committee) in FDA’s Center for Food

Safety and Applied Nutrition.

Nominations will be accepted for

current vacancies and vacancies that

will or may occur on the Committee

during the next 12 months.

FDA has special interest in ensuring

that women, minority groups, and the

physically handicapped are adequately

represented on advisory committees

and, therefore, extends particular

encouragement to nominations for

appropriately qualified female,

minority, or physically handicapped

candidates. Final selection from among

qualified candidates for each vacancy

will be determined by the expertise

required to meet specific agency needs

and in a manner to ensure appropriate

balance of membership.

DATES: Nominations should be received

by May 24, 1995.

ADDRESSES: All nominations for

membership, except for consumernominated members, should be sent to

Catherine M. DeRoever (address below).

All nominations for the consumernominated members should be sent to

Martha F. Waugh or Annette J. Funn

(address below).

FOR FURTHER INFORMATION CONTACT:

Regarding all nominations for

membership, except for consumernominated members: Catherine M.

DeRoever, Center for Food Safety

and Applied Nutrition (HFS–22),

Food and Drug Administration, 200

C St. SW., Washington, DC 20204,

202–205–4251.

Regarding all nominations for

consumer-nominated members:

Martha F. Waugh or Annette J.

Funn, Office of Consumer Affairs

(HFE–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–

5006.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations for members to

serve on the advisory committee listed

below. Individuals should have

expertise in the activity of the

Committee. Eight vacancies will occur

June 30, 1995.

Food Advisory Committee

The Committee provides advice

primarily to the Director, Center for food

Safety and Applied Nutrition, and as

needed, to the Commissioner of Food

and Drugs, and other appropriate

officials, on emerging food safety, food

science, and nutrition issues that FDA

considers of primary importance in the

next decade. The Committee also

provides advice and makes

recommendations on ways of

communicating to the public the

potential risks associated with these

issues and recommends approaches to

be considered in addressing them.

Criteria for Members

Persons nominated for membership

on the Committee shall be

knowledgeable in the fields of life

sciences, food science, risk assessment,

or other relevant scientific disciplines.

The Committee may include technically

qualified members who are identified
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Notices 20105

with consumer interests and are

recommended by either a consortium of

consumer-oriented organizations or

other interested persons.

Representatives of industry interests

will serve as liaisons to the regulated

industry. The term of office is up to 4

years.

Nomination Procedures

Interested persons may nominate one

or more qualified persons for

membership on the Committee.

Nominations shall state that the

nominee is willing to serve as a member

of the Committee and appears to have

no conflict of interest that would

preclude Committee membership.

Additionally, the nominee’s mailing

address, telephone number, and

curriculum vitae must accompany the

nominations. Potential candidates will

be asked by FDA to provide detailed

information concerning such matters as

financial holdings, employment,

consultancies, and research grants and/

or contracts to permit evaluation of

possible sources of conflict of interest.

Criteria for Consumer-Nominated

Members

Selection of representatives of

consumer interests will be conducted

through procedures that include use of

a consortium of consumer organizations

which has the responsibility for

screening, interviewing, and

recommending candidates for the

agency’s selection. Candidates from this

group, like all other candidates for

membership on the Committee, should

possess appropriate qualifications to

understand and contribute to the

Committee’s work.

Industry Representatives

Regarding nominations for members

representing industry interests, a letter

will be sent to each person or

organization that has made a

nomination and to other organizations

that have expressed an interest in

participating in the selection process

together with a complete list of all such

organizations and the nominees. The

letter will state that it is the

responsibility of each nominator or

organization that has expressed an

interest in participating in the selection

process to consult with the others and

to provide a consensus slate of possible

members representing industry interests

within 60 days. In the event that a slate

of nominees has not been provided

within 60 days, the agency will select an

industry representative for each such

vacancy from the entire list of industry

nominees to avoid delay or disruption

of the work of the Committee. The

agency is particularly interested in

nominees that possess the essential

scientific credentials needed to

participate fully and knowledgeably in

the Committee’s deliberations. In

addition to this expertise, the agency

believes that it would be an advantage

to the Committee’s work if the

individual(s) had special insight and

direct experience into specific

industrywide issues, practices, and

concerns that might not otherwise be

available to others not similarly

situated.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14,

relating to advisory committees.

Dated: April 17, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–10075 Filed 4–21–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0035]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; LUVOXTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

LUVOXTM 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 LUVOXTM

(fluvoxamine maleate). LUVOXTM is

indicated for the treatment of obsessions

and complusions in patients with

obsessive compulsive disorder.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

LUVOXTM (U.S. Patent No. 4,085,225)

from Duphar International, and the

Patent and Trademark Office requested

FDA’s assistance in determining this

patent’s eligibility for patent term

restoration. In a letter dated March 1,

1995, FDA advised the Patent and

Trademark Office that this human drug

product had undergone a regulatory

review period and that the approval of

LUVOXTM 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

LUVOXTM is 6,958 days. Of this time,

5,886 days occurred during the testing

phase of the regulatory review period,

while 1,072 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 became effective:

November 19, 1975. FDA has verified

the applicant’s claim that the date the

investigational new drug application