Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Notices 67081

While the Commissioner does not

need to reach the issue of whether

FDA’s decision not to provide further

opportunity to demonstrate or achieve

compliance was proper under § 601.5,

he notes that § 601.5 requirements have

been satisfied because Plascon’s

conduct was willful within the meaning

of § 601.5. Courts that have considered

the meaning of willfulness in the

context of license revocation

proceedings have noted that willful

conduct can be found when a person

acts with careless disregard of statutory

requirements. (See, e.g., Potato Sales

Co., Inc. v. United States Dept. of Agric.,

92 F.3d 800, 805 (9th Cir. 1996); Cox v.

United States Dept. of Agric., 925 F.2d

1102, 1105 (8th Cir. 1991), cert. denied,

502 U.S. 860 (1991); Lawrence v.

Commodity Futures Trading Corp., 759

F.2d 767, 773 (9th Cir. 1985); Finer Food

Sales Co. v. Block, 708 F.2d 774, 778

(D.C. Cir. 1983); American Fruit

Purveyors Inc. v. United States, 630 F.2d

370, 374 (5th Cir. 1980), cert. denied,

450 U.S. 997 (1981).) Plascon’s pattern

of continued noncompliance with the

applicable license standards and

regulations, despite ample notice from

the FDA of the firm’s noncompliance

and repeated assurances from Plascon

that the firm would come into

compliance, demonstrates careless

disregard of the applicable

requirements. Thus, the agency finds

that Plascon’s conduct was willful

within the meaning of § 601.5, and thus

it was not necessary to provide Plascon

with further opportunity to demonstrate

or achieve compliance.

The next issue for consideration is

whether the data and information

Plascon submitted raise a genuine and

substantial issue of fact for resolution at

a hearing (§ 12.24(b)(1).) FDA’s

proposed revocation of Plascon’s

establishment and product licenses is

based on Plascon’s failure to adhere to

the applicable regulations and the

standards in Plascon’s license

application, not on a finding that these

failures constitute a ‘‘danger to health.’’

(Letter from FDA to Plascon, May 5,

1994, at p. 1–3; 60 FR 57719.) FDA’s

focus on Plascon’s failure to comply

with the applicable regulations and

standards conforms to the applicable

regulations. (See § 601.5(b)(4).)

The grounds for revocation set forth

in § 601.5(b)(4) have been established in

this case. As described above, FDA’s

inspections documented Plascon’s

deviations from the applicable

regulations and standards during four

inspections between 1989 and 1993.

Plascon has not only failed to submit

any data and information challenging

FDA’s inspectional findings, but also

has admitted that the firm failed to

comply with the applicable regulations.

Indeed, by the firm’s own

characterization, the conditions

observed during the 1993 inspection,

which led to the suspension and

proposed revocation of Plascon’s

licenses, were ‘‘deplorable.’’ (See Letter

from Plascon to FDA, June 29, 1994, at

p. 3 (‘‘[I]t is a source of great regret’’ that

the:

conditions observed by FDA investigators

* * * during the[] December 13–17, 1993

inspection of [Plascon] were so deplorable,

resulting in the issuance of a Form FDA–483

with 66 inspectional observations * * *

[T]he facility was not operating in an

acceptable manner, and [Plascon] accepts full

responsibility for that extremely unfortunate

situation.);

see also id. at p. 2 (‘‘Without for a

moment seeking to justify or minimize

the deviations from regulatory

requirements that were observed during

the various FDA inspections over the

more than four year period of time

* * *’’); id. at p. 25 (‘‘The final

inspection, in December of 1993, was by

far the ‘worst’ of these inspections

* * *’’); id. at 28 (‘‘if the December

1993 inspection had been a completely

successful one, instead of the disaster

that it obviously was * * *’’); Letter

from Plascon to FDA dated February 21,

1994, Corrective Action Plan, at p. 2

(‘‘Plascon, Inc. has terminated

employees who were not following

proper protocol during the most recent

FDA inspection.’’).) Having conceded the existence of the

‘‘deplorable’’ conditions at Plascon, the

firm confines its challenge to the

proposed revocation of its licenses to

whether FDA established the existence

of a danger to health when the agency

suspended Plascon’s licenses on May 5,

1994. More specifically, Plascon argues

that the regulatory deficiencies observed

did not affect the quality of the Source

Plasma manufactured by the firm and

that FDA has not established the

existence of a ‘‘danger to health.’’ (Letter

from Plascon to FDA dated January 12,

1996, at p. 1.) However, while the issue

of whether the Commissioner had

reasonable grounds to believe that by

reason of the existence of the grounds

for revocation of Plascon’s licenses there

was ‘‘a danger to health’’ was relevant

to the decision to suspend the firm’s

licenses, it has no bearing on the

revocation of those licenses under

§ 601.5(b).

Plascon’s hearing request will be

granted only if the material submitted

shows that there is a genuine and

substantial issue of fact for resolution at

a hearing (§ 12.24(b)(1)). A hearing will

not be granted on factual issues that are

not determinative with respect to the

action requested (§ 12.24(b)(4)). As the

District of Columbia Circuit Court of

Appeals observed, ‘‘Only disputes over

facts that might affect the outcome of

the suit under the governing law will

properly preclude the entry of summary

judgment. Factual disputes that are

irrelevant or unnecessary will not be

counted.’’ Copanos & Sons v. FDA, 854

F.2d 510, 523 (D.C. Cir. 1988). Plascon’s

hearing request raises only an irrelevant

factual dispute, the resolution of which,

even if in Plascon’s favor, would have

no bearing on the merits of the

revocation of its licenses.

For the reasons set forth above, the

agency finds that Plascon, Inc., doing

business as Anderson Plasma Center,

has failed to show that there is a

genuine and substantial issue of fact

justifying a hearing on the revocation of

its establishment and product licenses.

The agency also finds that significant

deviations from the biologics

regulations and the standards set forth

in the firm’s licenses existed which

warrant revocation of Plascon’s licenses.

Therefore, under section 351 of the

Public Health Service Act (42 U.S.C.

262) and under §§ 12.28, 601.5, and

601.7, the Commissioner denies the

request for a hearing and revokes the

establishment (U.S. License No. 572–

003) and product licenses issued to

Plascon, Inc., doing business as

Anderson Plasma Center, for the

manufacture of Source Plasma.

Dated: December 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33373 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Program Announcement Number FDA–

CFSAN–98–1 Cooperative Agreement

for Validation of Analytical Methods,

Standards, and Procedures

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Center for Food

Safety and Applied Nutrition (CFSAN),

is announcing its intention to accept

and consider a single source application

for award of a cooperative agreement to

support AOAC International in the

amount of $100,000. The cooperative

agreement will provide support for the

Validation of Analytical Methods,

Standards, and Procedures.
67082 Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Notices

DATES: Submit applications by January

6, 1998.

ADDRESSES: An application is available

from and should be submitted to Robert

L. Robins (address below). Applications

hand carried or commercially delivered

should be addressed to the Park Bldg.,

12420 Parklawn Dr., rm. 3–40,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of

this notice: Robert L. Robins, Grants

Management Officer, or Rosemary

T. Springer, Grants Management

Specialist, Office of Regulatory

Affairs Support and Assistance

Management Branch, State

Contracts and Assistance

Agreements Branch (HFA–520),

Food and Drug Administration,

Park Bldg., 5600 Fishers Lane, rm.

3–40, Rockville, MD 20857, 301–

443–6170.

Regarding the programmatic aspects

of this program: Bernadette

McMahon, Office of Plant and Dairy

Foods and Beverages (HFS–337),

Center for Food Safety and Applied

Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–

4038.

SUPPLEMENTARY INFORMATION: FDA is

announcing its intention to accept and

consider a single source application

from AOAC International for supporting

the Validation of Analytical Methods,

Standards, and Procedures. FDA’s

authority to enter into grants and

cooperative agreements is set out in

section 301 of the Public Health Service

Act (42 U.S.C. 241). FDA’s research

program is described in the Catalog of

Federal Domestic Assistance at section

93.103. Before entering into cooperative

agreements, FDA carefully considers the

benefits such agreements will provide to

the public.

I. Background

Until 1979, AOAC International

operated as part of the U.S. FDA, whose

employees performed as Executive

Director and Journal Editor, among

other positions. At that time, on the

recommendation of an independent

panel, AOAC International became

independent of FDA and was

established as a nonprofit association.

Since the separation of FDA and

AOAC International, FDA has continued

to provide financial support to AOAC

International through a cooperative

agreement. In the beginning, FDA was

motivated to ensure that AOAC

International would have funds needed

to continue publishing new editions

(every 5 years) of Official Methods of

Analysis of AOAC (OMA), the

compilation of all methods validated

through the collaborative process,

which is of interest to regulated

industry. AOAC International no longer

requires FDA’s support to underwrite

the publication of OMA, which is now

AOAC International’s main source of

revenue. FDA’s current support for

AOAC International, both financially

and with activities of its employees, is

motivated by its recognition of AOAC

International’s critical role in

organizing, operating, and maintaining

an internationally recognized system for

establishing collaborated methods of

analysis. It is imperative to FDA that an

organization such as AOAC

International continue to function

efficiently, especially in scientific areas

in which internationally recognized

analytical methods are required to

support regulatory decisions.

AOAC International consists of the

following members: A governing board

(Board of Directors, including officers)

concerned with administration and

policy making; Official Methods Board;

Editorial Board; special and standing

committees which serve in advisory and

liaison capacities; other groups

concerned with development of

methods, publication, and general

activities; and the headquarters staff

which conducts the day-to-day

business.

In recent years, AOAC International

has initiated additional activities aimed

at the improvement of the analytical

sciences, including training programs

on critical subjects such as modern

analytical technologies, application of

quality assurance principles, and

statistical principles and applications.

The association established a Research

Foundation to assess and certify

commercial test kits, defined an

additional level of validated methods

(the ‘‘peer verified’’ methods), and is

investigating the potential for

developing analytical standard reference

materials. AOAC International has

embraced opportunities to use

electronic media to distribute its

validated methods and other supporting

materials through use of the World

Wide Web and CD-ROM formats.

II. Purpose of Agreement

The primary purpose is to provide

financial and scientific support for

AOAC International cooperative

volunteer system of scientific analytical

methods development and approval.

This system produces methods that

meet predetermined levels of quality for

analysis of foods, animal feeds, drugs

and cosmetics; such methods are critical

to the acceptability of regulatory

analytical results performed by FDA and

by the regulated industry. AOAC

International has excelled in planning,

coordinating, and managing the

activities essential to developing tested

analytical procedures applicable to a

wide range of sample types of interest

to industry, government, and academia.

This is one of very few programs which

provide methodology validated through

a formal interlaboratory collaborative

study process.

To accomplish this overall goal,

AOAC International will:

1. Develop standards and criteria for

evaluation of results in analytical

methods validation, balancing the needs

for statistical acceptability, international

harmonization, and practicality in an

era of shrinking fiscal resources.

2. Identify needs for new and

improved analytical methods for food

composition and safety, vitamins and

nutrients, food additives, pesticide and

industrial chemical residues, drug

formulations, animal drug residues,

cosmetics chemistry and microbiology,

color additives and any other products

or substances affecting the public health

and safety.

3. Recruit and support logistically the

volunteer experts necessary to the

successful development, review, and

testing of needed methods.

4. Apply quality assurance principles

to validation studies.

5. Encourage FDA and regulated

industry to do more related research in

analytical sciences.

6. Sponsor and participate in

international forums.

7. Promote wider use of validated

methods.

8. Increase opportunities for

interaction of FDA-related science in

international activities.

AOAC International maintains no

laboratories itself, conducts no research,

performs no tests. The actual work of

developing and testing methods is done

by scientists of Federal, State, provincial

and municipal regulatory agencies,

colleges and universities, commercial

firms, and other private laboratories.

AOAC International provides the

framework within which the

collaborative study process occurs. With

AOAC International as a focal point of

analytical expertise, sufficient

cooperating volunteer members can be

found to effect the complex process of

testing a method simultaneously in

multiple laboratories. AOAC

International staff members facilitate

logistics required for operations,

including the necessary meetings,

recruitment of volunteers and

collaborating laboratories, the voting
Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Notices 67083

process, and eventual publication in

both the Journal of AOAC International

and OMA. AOAC International’s

existence as an internationally

recognized organization means that

AOAC International official methods are

internationally acceptable based on the

association’s prior efforts to

‘‘harmonize’’ standards of

acceptability.Methods are developed

and subjected to interlaboratory

collaborative study by Associate

Referees, under the guidance of General

Referees and the Official Methods Board

and its Committees. AOAC International

staff and methods committee members

assist in recruiting laboratories with

appropriate expertise to participate in

approved collaborative studies.

Volunteer statisticians assigned to the

Committee by AOAC International assist

the Associate Referee in evaluating

study results. If the statistical evaluation

of analytical results demonstrates that

the method is capable of producing

accurate and precise results in multiple

laboratories, it is recommended for

official status. After assenting mail vote

by the association, the description of the

newly approved official method is

incorporated by the editorial staff into

the next annual revision of OMA;

details of the collaborative study are

published in the Journal of AOAC

International. AOAC International conducts an

annual international meeting, which

includes presentation of symposia,

reports methods and collaborative

studies, and deliberation decisions by

the Official Methods Board and its

Committees.

III. Substantive Involvement by the

FDA

FDA supports AOAC International

under this cooperative agreement

because the existence of AOAC

Interantional and its programs benefits

both FDA and other regulators

monitoring regulated products;

regulated industries benefit equally

from these activities. The availability of

validated methods also benefits FDAregulated industry which needs

validated analytical methods to comply

with regulatory requirements under the

Federal Food, Drug, and Cosmetic Act.

Beyond the financial support, this

agreement also commits FDA’s

personnel to participation in the

scientific and administrative operations

of AOAC International.

Members of AOAC International are

chemists, microbiologists, toxicologists

and others engaged in the analysis of

foods, animal feeds, drugs, agricultural

commodities and environmental

matrixes. Members identify and develop

methods to be tested and organize the

interlaboratory validation studies.

Members receive and review the results

of validation studies. Members receive

and review methods recommendations,

and members study, devise and

recommend policies and protocols

addressing methods, validation studies,

quality assurance, safety and statistical

analysis. FDA involvement in AOAC

International activities continues at a

high level, with a significant percentage

of Associate and General Referee and

Committee positions filled by FDA

personnel. Any laboratory or individual

may participate in the development,

testing, and collaborative study of new

or improved methods. The international

voluntary participation among scientists

in government, academic, and industry

laboratories enhances the credibility

and acceptability of methods and saves

time and money through shared efforts

and costs.

IV. Review Procedure

This application will undergo dual

peer review. An ad hoc review panel of

experts will review and evaluate the

application based on its scientific merit.

A second level review will be

conducted by the National Advisory

Environmental Health Sciences Council.

V. Mechanism of Support

A. Award Instrument

Support for this program, if granted,

will be in the form of a cooperative

agreement. In 1998, FDA is providing

approximately $100,000 for this award.

The award will be subject to all policies

and requirements that govern the

research grant programs of the Public

Health Service (PHS), including the

provisions of 42 CFR part 52, 45 CFR

part 74, and the PHS Grants Policy

Statement.

B. Length of Support

The length of support will be one (1)

year with the possibility of an

additional four (4) years of

noncompetitive support. Continuation,

beyond the first year, will be based

upon performance during the preceding

year and the availability of Federal

fiscal year appropriations.

C. Memorandum of Understanding

(MOU)

FDA and AOAC International will

develop a MOU to cover and clarify

AOAC International’s publication of

FDA manuals.

VI. Reporting Requirement

Program progress reports and

financial status reports will be required

annually, based on date of award. These

reports will be due within 30 days after

the end of the budget period. A final

program progress report and financial

status report will be due 90 days after

expiration of the project period of the

cooperative agreement.

VII. Application Due Date

Applications should be submitted to

Robert L. Robins (address above) by

January 6, 1998.

Dated: December 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33371 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0160]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Food Labeling: Nutrient Content

Claims and Health Claims; Restaurant

Foods’’ has been approved by the Office

of Management and Budget (OMB)

under the Paperwork Reduction Act of

1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: On

September 17, 1997, the agency

submitted the proposed information

collection to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0349. The

approval expires on November 30, 2000.

Dated: December 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33374 Filed 12-22-97; 8:45 am]

BILLING CODE 4160–01–F