67078 Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Notices

TABLE 3.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.142 13,000 24 316,800 0.41 132,000

225.158 13,000 24 316,800 0.25 79,200

225.180 13,000 24 316,800 0.16 52,800

225.202 13,000 24 316,800 1.5 475,200

Total 739,200

1There are no capital costs or operating and maintenance costs associated with this collection of information.

2 Commercial feed mills.

TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.142 45,000 3 135,000 0.16 22,500

225.158 45,000 3 135,000 0.16 22,500

225.180 45,000 3 135,000 0.083 11,250

225.202 45,000 3 135,800 0.5 67,500

Total 123,750

1There are no capital costs or operating and maintenance costs associated with this collection of information.

2 Mixer-feeders.

The estimate of the times required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

finally calculate the total burden hours

(i.e., number of recordkeepers, number

of medicated feeds being manufactured,

etc.) is derived from agency records and

experience.

Dated: December 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33487 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 94N–0376]

Plascon, Inc., dba Anderson Plasma

Center; Denial of Request for a Hearing

and Revocation of U.S. License No.

572–003

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is denying the

request for a hearing and revokes the

establishment license (U.S. license

number 572–003) and product license

issued to Plascon, Inc., doing business

as Anderson Plasma Center, for the

manufacture of Source Plasma. The

agency finds that there is no genuine

and substantial issue of fact justifying a

hearing on the revocation of Plascon’s

licenses. The licenses are revoked due

to the firm’s failure to comply with the

applicable biologics regulations and

license standards designed to ensure the

safety, purity, and potency of the

manufactured products.

DATES: The revocation of the

establishment license (U.S. License No.

572–003) and product license is

effective December 23, 1998.

FOR FURTHER INFORMATION CONTACT:

Dano B. Murphy, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November

17, 1995 (60 FR 57719), FDA announced

an opportunity for a hearing on its

proposal to revoke the establishment

license (U.S. License No. 572–003) and

product license issued to Plascon, Inc.,

doing business as Anderson Plasma

Center, for the manufacture of Source

Plasma (60 FR 57719). By letter dated

December 12, 1995, Plascon requested a

hearing on the proposed revocation. The

agency is denying the request for a

hearing and is revoking U.S. License No.

572–003, which includes the

establishment license and product

license, because the agency finds there

is no genuine and substantial issue of

fact regarding the basis for the proposed

revocation for the firm’s failure to

comply with applicable Federal

regulations and license standards. FDA

has documented Plascon’s failure to

conform to such standards during

inspections of Plascon in 1989, 1991,

1992, and 1993.

During a December 1989 inspection of

Plascon, FDA investigators documented

numerous deviations from the current

good manufacturing practice (CGMP)

regulations. The deviations included,

but were not limited to, the following:

(1) Failure to adequately determine

donor suitability (part 606 (21 CFR part

606)) (§ 606.100(b)(1)) and (part 640 (21

CFR part 640)) (§ 640.63(c)); (2) failure

to maintain accurate donor records

(§ 606.160(b)(1)); (3) failure to ensure

that personnel were competent in the

performance of their duties

(§ 606.20(b)); and (4) poor record

keeping practices related to quality

control, equipment calibration, and

maintenance (§ 606.160(b)(5) and (b)(7)).

An FDA inspection of Plascon in

September 1991 revealed similar CGMP

deficiencies, as well as additional

violations, including: (1) Failure to

follow the standard operating

procedures (SOP’s) for documenting

donor weight loss of 10 or more pounds

or referring these donors to the

physician on call (§ 606.100); (2) failure

to record donor blood losses

(§ 606.160(b)); (3) failure to maintain

adequate facilities (§ 606.40); and (4)

failure to properly maintain equipment

(§ 606.60).

During an inspection of Plascon from

August through October 1992, FDA

inspectors found CGMP deviations

similar to those documented during the
Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Notices 67079

previous two inspections, despite

Plascon’s assurances that the firm was

in compliance with Federal regulations.

The violations observed during this

inspection included: (1) Failure to

adequately investigate donor adverse

reactions (§§ 606.170(a), 606.100(b)(9),

and 606.160(b)(1)(iii)); (2) failure to

maintain complete and accurate records

of donors (§ 606.160(b)(1)); (3) failure to

maintain the plasma at a proper storage

temperature (§§ 606.100(b)(10) and

640.76(a)(1)); (4) failure to adequately

observe, standardize, or calibrate

equipment (§§ 606.100(b)(15) and

606.60); (5) failure to maintain adequate

facilities (§ 606.40); and (6) failure to

follow SOP’s (§ 606.100). FDA issued a

warning letter to Plascon on November

12, 1992. In the warning letter, FDA

stated that Plascon was responsible for

ensuring that operations at all of its

centers were in full compliance with the

Federal Food, Drug, and Cosmetic Act

(the act), 21 U.S.C. 301 et seq., and its

implementing regulations, and

requested that Plascon take prompt

action to correct the deviations noted.

The warning letter notified Plascon that

failure to take prompt corrective action

could result in regulatory action without

further notice, including license

suspension and/or revocation. On

January 6, 1993, Plascon sent a letter to

FDA promising corrective action.

FDA conducted another inspection of

Plascon in July 1993 and documented

continued deficiencies, including: (1)

Failure to adequately determine donor

suitability (§§ 606.100(b)(1) and

640.63(c)); (2) failure to maintain

adequate facilities (§ 606.40); and (3)

failure to provide adequate equipment

maintenance (§ 606.60).

At the conclusion of each of these

inspections, FDA issued to Plascon a list

of observations from the inspection

(Form FDA–483), which detailed

Plascon’s continuing noncompliance

with the applicable regulations and

license standards. After each inspection,

Plascon promised corrective action.

Subsequently, FDA conducted an

inspection of Plascon on December 11

through December 17, 1993, and FDA

again documented numerous CGMP

deviations. The CGMP violations

observed included the following, among

others: (1) Failure to adequately

determine donor suitability

(§§ 606.100(b)(1) and 640.63(c)); (2)

failure to investigate adverse donor

reactions (§ 606.170(a)); (3) failure to

perform adequate physical examinations

on donors (§ 640.63(b) and (c)); (4)

failure to perform and maintain records

of quality control for equipment and

reagents (§§ 606.60(a), 606.160(b)(5) and

(b)(7)); and (5) failure to maintain

complete and accurate records and to

follow SOP’s (§§ 606.160(b) and

640.65(b)(3)).

Due to the serious nature of the

deviations from the applicable

regulations and the standards in

Plascon’s licenses, which the agency

determined to constitute a danger to

health, on January 11, 1994, FDA

suspended Plascon’s licenses and

denied the firm’s pending license

supplements for automated collection of

Source Plasma. FDA’s suspension letter

noted that the basis for the suspension

was Plascon’s serious noncompliance

with donor protection standards that are

designed to assure a continuous and

healthy donor population, and the

firm’s noncompliance with standards

designed to assure the continued safety,

purity, potency, and quality of the

manufactured products. (Letter from

FDA to Plascon, January 11, 1994, at p.

4.) The suspension letter stated that

‘‘[t]he nature of the deficiencies * * *

leads us to conclude that they are a

direct consequence of [Plascon’s]

disregard for the applicable regulations

and standards in [Plascon’s] license

application.’’ (Id.) The suspension letter

notified Plascon that its licenses were

suspended and that FDA would proceed

to revoke Plascon’s licenses unless the

firm requested that revocation be held

in abeyance pending resolution of the

matters involved and provided FDA

with a written description of the

‘‘specific actions taken to correct all

deficiencies noted’’ in the suspension

letter.

By letter dated January 20, 1994,

Plascon requested that FDA hold the

proposed revocation of its licenses in

abeyance and extend until January 31,

1994, the time for Plascon to prepare

and submit a corrective action plan. On

January 27, 1994, FDA granted the

request for a time extension to submit

the corrective action plan. By letter

dated January 28, 1994, Plascon

requested that FDA extend until

February 21, 1994, the time for Plascon

to submit a corrective action plan. On

February 10, 1994, FDA granted the

second-time extension request. By letter

dated February 21, 1994, Plascon

submitted its corrective action plan to

FDA.

After considering Plascon’s corrective

action plan, FDA, by letter dated May 5,

1994, denied the firm’s request that the

license revocation be held in abeyance.

FDA explained that the

‘‘current and previous inspections of

[Plascon] have revealed continuing

significant deviations from applicable

regulations and standards specified in

[Plascon’s] license and establish[] a pattern of

failure to implement appropriate and lasting

corrections of these deviations.’’

(Letter from FDA to Plascon dated May

5, 1994, at p. 1.) FDA advised Plascon

that its corrective action plan was

incomplete and inadequate and detailed

some of the plan’s inadequacies. In

addition, FDA explained that the

‘‘nature of the deficiencies and

continued noncompliance * * *

demonstrates careless disregard for the

applicable regulations and the standards

of [Plascon’s] license.’’ (Id. at p. 2.)

FDA’s letter notified Plascon that ‘‘[i]n

cases involving willfulness, the agency

need not provide an opportunity for the

licensee to demonstrate or achieve

compliance,’’ and that FDA was

‘‘initiating proceedings to revoke’’

Plascon’s licenses. (Id.)

Subsequently, in the Federal Register

of November 17, 1995, FDA announced

a notice of opportunity for a hearing

(NOOH) on the proposed revocation of

the establishment license and product

license issued to Plascon. In the NOOH,

FDA advised Plascon that a request for

a hearing may not rest upon mere

allegations or denials, but must set forth

a genuine and substantial issue of fact

that requires a hearing (60 FR 57719 at

57720). The NOOH further stated that if

it appeared conclusively from the face

of the data, information, and factual

analyses submitted in support of the

request for a hearing that there was no

genuine and substantial issue of fact for

resolution at a hearing, the

Commissioner of Food and Drugs (the

Commissioner) would deny the hearing

request (60 FR 57719 at 57720).

In a letter dated December 12, 1995,

Plascon requested a hearing on the

proposed license revocation. On January

12, 1996, Plascon submitted ‘‘data and

information’’ in support of its request.

(See § 12.24 (21 CFR 12.24).) In its letter,

Plascon stated that the firm ‘‘does not

deny that during a series of inspections

between 1989 and 1993 by FDA

inspectors, a variety of deviations from

the applicable federal regulations were

observed.’’ (Letter from Plascon to FDA,

January 12, 1996, at p. 1–2.) However,

Plascon argued that FDA’s

determination that Plascon’s continued

operation posed a danger to health was

not supported by an adequate factual

basis. Plascon argued that a ‘‘reasonable

and valid connection must be

established between the deviations

noted [by FDA] and the ‘danger to

health’ alleged.’’ (Id. at p. 1.) Plascon

further argued that a hearing was

necessary so that the ‘‘largely

unsupported conclusion of a public

health danger can be set forth, explored,

and tested during the course of a

hearing.’’ (Id.)
67080 Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Notices

Plascon’s letter of January 12, 1996,

also referred to and enclosed a letter

that Plascon sent to FDA on June 29,

1994, regarding the disposition of

inventory of Source Plasma on hand at

Plascon when FDA suspended Plascon’s

licenses. In its June 29, 1994, letter, the

firm stated that it did not seek to

‘‘justify or minimize the deviations from

regulatory requirements that were

observed during the various FDA

inspections’’ (letter from Plascon to

FDA, June 29, 1994, at p. 2), and

conceded that the conditions at

Plascon’s facilities during the December

1993 inspection were ‘‘deplorable.’’ (Id.

at p. 3.) Nevertheless, Plascon argued

that ‘‘the safety, purity, potency, and

quality of much of the Source Plasma

collected during that time period can

indeed be assured.’’ (Id. at p. 2.)

II. Applicable Regulations

In accordance to § 601.6 (21 CFR

601.6), whenever the Commissioner has

reasonable grounds to believe that any

of the grounds for revocation of a

license exist, and that by reason thereof

there is a danger to health, he may

notify the licensee that his license is

suspended (§ 601.6(a).) Upon

suspension of a license, the

Commissioner shall either: (1) Proceed

in accordance to the provisions of

§ 601.5(b) (21 CFR 601.5(b)) to revoke

the license; or (2) if the licensee agrees,

hold revocation in abeyance pending

resolution of the matters involved

(§ 601.6(b).)

The grounds for revocation are set

forth at § 601.5(b). In accordance to

§ 601.5(b)(4), if the Commissioner finds

that the establishment or the product for

which a license has been issued fails to

conform to the applicable standards

established in the license and the

regulations designed to ensure the

continued safety, purity, and potency of

the manufactured product, he shall

notify the licensee of his intention to

revoke the license, setting forth the

grounds for, and offering an opportunity

for a hearing on, the proposed

revocation. Except as provided in

§ 601.6 or in cases involving willfulness,

the notification of intent to revoke shall

provide a reasonable period for the

licensee to demonstrate or achieve

compliance with the applicable

requirements before proceedings will be

instituted for revocation of the license

(§ 601.5(b).)

The procedures for hearings on the

revocation of biologics licenses are set

forth in part 12 (21 CFR part 12). (See

§ 601.7.) The criteria for deciding

whether to grant or deny a hearing are

stated in § 12.24(b). These regulations

provide that a request for a hearing may

not rest upon mere allegations or

denials, but must set forth a genuine

and substantial issue of fact that

requires a hearing (§ 12.24(b)(1)(2).) If it

conclusively appears from the face of

the data, information, and factual

analyses in the request for a hearing that

there is no genuine and substantial issue

of fact that requires a hearing on the

revocation of the license, the

Commissioner will deny the hearing

request and enter summary judgment

against the licensee. (§ 12.24(b)(1); see

also Costle v. Pacific Legal Found., 445

U.S. 198, 214–15 (1980); Weinberger v.

Hynson, Westcott & Dunning, Inc., 412

U.S. 609, 620–21 (1973).) Moreover,

where the issues raised in the hearing

request are, even if true, legally

insufficient to alter the decision, the

Commissioner need not grant a hearing.

(§ 12.24(b)(4) (hearing request will not

be granted ‘‘if the Commissioner

concludes that the action would be the

same even if the factual issue were

resolved in the way sought’’).)

Therefore, to warrant a hearing, Plascon

must set forth a genuine and substantial

issue of fact concerning the grounds for

revocation of its licenses.

III. Plascon’s Hearing Request and the

Commissioner’s Findings

Plascon’s challenge to the proposed

revocation of its establishment and

product licenses is a narrow one.

Plascon’s hearing request and the data

and information the firm submitted in

support of its hearing request do not

challenge whether Plascon failed to

comply with applicable regulations and

the standards set forth in the firm’s

licenses; instead, Plascon only disputes

whether Plascon’s deviations from

FDA’s regulations constitute a ‘‘danger

to health.’’ (See, e.g., Letter from

Plascon to FDA, January 12, 1996, p. 3

(‘‘The fact that there were deviations

from regulatory requirements * * *

does not automatically establish that a

‘danger to health’ was present. Danger to

who? The employees? The donors?

* * * These are factual issues that

require exploration at the requested

hearing * * *’’).) For the reasons set

forth below, the agency finds that there

is no genuine and substantial issue of

fact justifying a hearing and therefore

denies Plascon’s request for a hearing.

Before proceeding to the basis for

Plascon’s request for a hearing, the

agency notes that FDA’s decision to

initiate revocation proceedings without

providing Plascon with a further

opportunity to demonstrate or achieve

compliance was appropriate. As noted

above, FDA’s regulations provide:

Except as provided in [21 CFR] 601.6 or in

cases involving willfulness, the notification

[of intent to revoke] shall provide a

reasonable period for the licensee to

demonstrate or achieve compliance with the

requirements of this chapter, before

proceedings will be instituted for revocation

of the license.

(§ 601.5(b).)

After FDA suspended Plascon’s

licenses in January 1994, in response to

Plascon’s request, FDA held revocation

of the firm’s licenses in abeyance

pending resolution of the matters

involved. (See § 601.6(b).) FDA’s

January 11, 1994, suspension letter

notified Plascon that FDA would

proceed with revocation unless, inter

alia, the firm notified FDA in writing of

the:

specific actions taken to correct all

deficiencies noted in this letter including a

detailed explanation of all retraining of all

personnel as well as the means by which

such training is to be evaluated.

(Letter from FDA to Plascon, January 11,

1994, at p. 6.)

FDA granted both of the extensions

that Plascon requested for submission of

a corrective action plan. Subsequently,

after considering Plascon’s February 21,

1994, submission, FDA advised Plascon

by letter that the firm’s corrective action

plan was incomplete and inadequate

and that the firm’s claim that sufficient

corrective actions would be

implemented and sustained was not

credible in light of the firm’s careless

disregard of the applicable regulations

and standards. In this letter, FDA also

notified Plascon that it no longer would

hold the license revocation in abeyance

and that the agency would initiate

revocation proceedings. (Letter from

FDA to Plascon, May 5, 1994, at p. 2.)

Citing the May 5, 1994, letter, the

November 17, 1995, NOOH also noted

Plascon’s ‘‘careless disregard of the

applicable regulations and standards’’

and stated that FDA had advised

Plascon ‘‘that no additional time would

be provided in which to demonstrate

compliance’’ before FDA would initiate

revocation proceedings (60 FR 57710 at

57720).

The agency notes that Plascon’s

hearing request and the data and

information it submitted in accordance

to that request do not challenge the May

5, 1994, letter’s assertion that Plascon

had acted in careless disregard of the

applicable regulations and standards.

Similarly, the firm has not objected to

FDA’s decision to institute revocation

proceedings without providing Plascon

further opportunity to demonstrate or

achieve compliance. (Letter from

Plascon to FDA, December 12, 1995;

Letter from Plascon to FDA, January 12,

1996.)
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.