29148 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices

B. Burden Estimate

Table 1 of this document provides an

estimate of the annual reporting burden

for requests for special protocol

assessment. The procedures for

requesting special protocol assessment

that are set forth in the guidance have

not been previously described by the

agency, although the PDUFA goals and

the requirements of section 505(b)(4)(B)

of the act (21 U.S.C. 355 (b)(4)(B)) have

been in effect since October and

November 1998, respectively, as

follows:

1. Notification for a Carcinogenicity

Protocol

Based on data collected from the

review divisions and offices within

CDER and CBER, including the number

of carcinogenicity protocols submitted

for review in the first half of fiscal year

(FY) 1999 and the number of INDs for

new molecular entities that were

received by the agency per year over the

last 5 years, CDER and CBER anticipate

that approximately 30 respondents will

notify the agency of an intent to request

special protocol assessment of a

carcinogenicity protocol. The agency

further estimates that the total annual

responses, i.e., the total number of

notifications that will be sent to CDER

and CBER, will be 60, based on data

collected from the offices within CDER

and CBER. Therefore, the agency

estimates that there will be

approximately two responses per

respondent. The hours per response,

which is the estimated number of hours

that a respondent would spend

preparing the notification and

background information to be submitted

in accordance with the guidance, is

estimated to be approximately 8 hours.

While FDA has not finalized the

separate guidance describing

background information that should be

submitted with notification of a

carcinogenicity protocol for assessment,

the agency anticipates that it will take

respondents approximately 8 hours to

gather and copy articles and study

reports that are relevant to the

carcinogenicity protocol. Therefore, the

agency estimates that respondents will

spend 480 hours per year notifying the

agency of an intent to request special

protocol assessment of a carcinogenicity

protocol.

2. Requests for Special Protocol

Assessment

Based on data collected from the

review divisions and offices within

CDER and CBER, including the number

of requests for special protocol

assessment in the first half of FY 1999,

the number of INDs for new molecular

entities that were received by the agency

per year over the past 5 years, the

number of sponsors who have submitted

protocols for agency review in the past

and in the first half of FY 1999, and the

number of end-of-phase 2/prephase 3

meetings that occur between

respondents and the agency per year,

FDA anticipates that 70 respondents

will request special protocol assessment

per year. The total annual responses are

the total number of requests for special

protocol assessment that are submitted

to CDER and CBER in 1 year. Based on

data collected from the review divisions

and offices within CDER and CBER,

FDA estimates that it will receive

approximately 180 requests for special

protocol assessment per year. Therefore,

the agency estimates that there will be

approximately 2.57 responses per

respondent. The hours per response is

the estimated number of hours that a

respondent would spend preparing the

information to be submitted with a

request for special protocol assessment,

including the time it takes to gather and

copy questions to be posed to the

agency regarding the protocol and data,

assumptions, and information needed to

permit an adequate evaluation of the

protocol. Based on estimates provided

by the regulated industry and on the

agency’s experience in requesting

similar information, FDA estimates

approximately 15 hours on average

would be needed per response.

Therefore, FDA estimates that 2,700

hours will be spent per year by

respondents requesting special protocol

assessment. Overall, FDA anticipates

that respondents will spend 3,180 hours

per year to participate in the programs

described in the guidance.

In the Federal Register of February 9,

2000 (65 FR 6377), the agency requested

comments on the proposed collections

of information. Eight comments were

received, however they were related to

the Protocol Assessment and not to the

collection of information.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Notification and Requests Number of

Respondents

Number of Responses

per Respondent

Total Annual

Responses Hours per Response Total Hours

Notification for Carcinogencity Protocols30 2.0 60 8 480

Requests for Special Protocol Assessment70 2.57 180 15 2,700

Total 3,180

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

Dated: May 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13304 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1219]

Biological Products; Bacterial

Vaccines and Related Biological

Products; Revocation of Biologics

Licenses

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of certain biologics licenses.

This action was taken at the voluntary

request of the licensees in response to

a proposed order for the Implementation

of Efficacy Review for Bacterial

Vaccines and Related Biological

Products.

DATES: The revocation of the biologics

license for the manufacture of

Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices 29149

Polyvalent Bacterial Vaccines with ‘‘no

U.S. Standard of Potency,’’

manufactured by Hollister-Stier

Laboratories, LLC, U.S. license 1272,

became effective August 3, 2000. The

revocation of the biologics license for

the manufacture of Diphtheria and

Tetanus Toxoids and Pertussis Vaccine

Adsorbed, Diphtheria and Tetanus

Toxoids Adsorbed, Diphtheria Toxoid

Adsorbed, and Tetanus Toxoid

Adsorbed, manufactured by BioPort

Corp., U.S. license 1260, became

effective November 20, 2000. Other

products under these licenses are not

affected by this revocation.

FOR FURTHER INFORMATION CONTACT:

Astrid L. Szeto, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

May 15, 2000 (65 FR 31003), FDA

issued a proposed order to accept the

conclusions and recommendations of

the Vaccines and Related Biological

Products Advisory Committee

(VRBPAC) and the Panel on Review of

Allergenic Extracts (the Allergenics

Panel) concerning the safety,

effectiveness, and labeling of certain

bacterial vaccines and related biological

products that were previously classified

into Category IIIA (remaining on the

market pending further studies in

support of effectiveness). On the basis of

the Allergenics Panel and the VRBPAC

findings, FDA proposed to reclassify

certain Category IIIA products into

Category I (safe, effective, and not

misbranded) or Category II (unsafe,

ineffective, or misbranded). This action

was taken under the reclassification

review procedures specified in 21 CFR

601.26. The proposed order also

announced the agency’s intention to

revoke the biologics licenses for those

bacterial vaccines and related products

classified as Category II (unsafe,

ineffective, or misbranded).

Certain Category IIIA bacterial

vaccines and toxoids with standards of

potency listed in the proposed order

were classified into two categories based

upon their use as a primary immunogen

or as a booster. Diphtheria and Tetanus

Toxoids Adsorbed, and Tetanus Toxoid

Adsorbed manufactured by BioPort

Corp. were recommended by the

VRBPAC for classification into Category

II (unsafe, ineffective, or misbranded)

for primary immunization and Category

I (safe, effective, and not misbranded)

for booster immunization.

Similarly, certain bacterial vaccines

and related biological products listed in

the proposed order were recommended

for classification into Category II for

both diagnosis and immunotherapy by

the Allergenics Panel. Polyvalent

Bacterial Vaccines with ‘‘no U.S.

Standard of Potency,’’ manufactured by

Hollister-Stier Laboratories, LLC, was

recommended for classification into

Category II for both diagnosis and

immunotherapy by the Allergenics

Panel.

FDA agreed with the

recommendations of the VRBPAC and

the Allergenics Panel to reclassify the

above cited products into Category II for

their respective indications, and in the

proposed order provided notice of the

agency’s intent to revoke the licenses to

manufacture these products. On June

19, 2000, Hollister-Stier Laboratories,

LLC, submitted a letter to FDA

voluntarily requesting revocation of its

license to manufacture Polyvalent

Bacterial Vaccines with ‘‘no U.S.

Standard of Potency.’’ On August 9,

2000, BioPort Corp. submitted a letter to

FDA voluntarily requesting revocation

of its license to manufacture Diphtheria

and Tetanus Toxoids Adsorbed, and

Tetanus Toxoid Adsorbed. In its August

9, 2000, letter, BioPort Corp. also

voluntarily requested revocation of its

license to manufacture Diphtheria and

Tetanus Toxoids and Pertussis Vaccine

Adsorbed, and Diphtheria Toxoid

Adsorbed, although these products were

not included in the proposed order.

The proposed order announced that

the agency would publish a notice of

opportunity for a hearing on the

revocation of the license of each product

classified in Category II. BioPort Corp.

and Hollister-Stier Laboratories waived

their opportunity for a hearing when

they voluntarily requested license

revocation for their reclassified Category

II products.

Accordingly, under the provisions of

21 CFR 601.5(a), section 351 of the

Public Health Service Act, and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68), FDA revoked the biologics

license issued to Hollister-Stier,

Laboratories, LLC, U.S. license 1272, for

the manufacture of Polyvalent Bacterial

Vaccines with ‘‘no U.S. Standard of

Potency,’’ effective August 3, 2000; and

FDA revoked the biologics license

issued to BioPort Corp., U.S. license

1260, for the manufacture of Diphtheria

and Tetanus Toxoids and Pertussis

Vaccine Adsorbed, Diphtheria and

Tetanus Toxoids Adsorbed, Diphtheria

Toxoid Adsorbed, and Tetanus Toxoid

Adsorbed effective November 20, 2000.

Dated: May 9, 2001.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 01–13306 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96P–0484]

Blood Products Advisory Committee,

Medical Devices Panel;

Reclassification of Autopheresis-C

System From Class III to Class II

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of panel

recommendation.

SUMMARY: The Food and Drug

Administration (FDA) is issuing for

public comment the recommendation of

the Blood Products Advisory

Committee, Medical Devices Panel (the

Panel) to reclassify the Autopheresis-C

System, intended for routine collection

of blood and blood components, from

class III to class II. The Panel made this

recommendation after reviewing the

reclassification petition submitted by

Baxter Healthcare Corp. (Baxter). FDA is

also issuing for public comment its

tentative findings on the Panel’s

recommendation. After considering any

public comments on the Panel’s

recommendation and FDA’s tentative

findings, FDA will approve or deny the

reclassification petition by order in the

form of a letter to the petitioner. FDA’s

decision on the reclassification petition

will be announced in the Federal

Register.

DATES: Submit written comments by

August 13, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, 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 (Regulatory Authorities)

The Federal Food, Drug, and Comestic

Act (the act) (21 U.S.C. 301 et seq.), as

amended by the Medical Device

Amendments of 1976 (the 1976

amendments) (Public Law 94–295), the