Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices 29147

Dated: May 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13303 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–0084]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Guidance

for Industry on Special Protocol

Assessment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (PRA).

DATES: Submit written comments on the

collection of information by June 28,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION:

I. Background

In compliance with 44 U.S.C. 3507,

FDA has submitted the following

proposed collection of information to

OMB for review and clearance.

Guidance for Industry on Special

Protocol Assessment

FDA is issuing a guidance on agency

procedures to evaluate issues related to

the adequacy of certain proposed

studies. The guidance describes

procedures for sponsors to request

special protocol assessment and for the

agency to act on such requests. The

guidance provides information on how

the agency will interpret and apply

provisions of the Food and Drug

Administration Modernization Act of

1997 and the specific Prescription Drug

User Fee Act of 1992 (PDUFA) goals for

special protocol assessment associated

with the development and review of

PDUFA products.

The guidance describes two

collections of information: (1) The

submission of a notice of intent to

request special protocol assessment of a

carcinogenicity protocol, and (2) the

submission of a request for special

protocol assessment.

II. Notification for a Carcinogenicity

Protocol

As described in the guidance, a

sponsor interested in agency assessment

of a carcinogenicity protocol should

notify the appropriate division in FDA’s

Center for Drug Evaluation and Research

(CDER) or Center for Biologics

Evaluation and Research (CBER) of an

intent to request special protocol

assessment at least 30 days prior to

submitting the request. With such

notification, the sponsor should submit

relevant background information so that

the agency may review reference

material related to carcinogenicity

protocol design prior to receiving the

carcinogenicity protocol. The agency is

currently drafting a separate guidance

describing the type of information that

would be appropriate to submit before

requesting carcinogenicity protocol

assessment.

III. Request for Special Protocol

Assessment

In the guidance, CDER and CBER ask

that a request for special protocol

assessment be submitted as an

amendment to the investigational new

drug application (IND) for the

underlying product and that it be

submitted to the agency in triplicate

with Form FDA 1571 attached. The

agency also suggests that the sponsor

submit the cover letter to a request for

special protocol assessment via

facsimile to the appropriate division in

CDER or CBER. Agency regulations (21

CFR 312.23(d)) state that information

provided to the agency as part of an IND

is to be submitted in triplicate and with

the appropriate cover form, Form FDA

1571. An IND is submitted to FDA

under existing regulations in part 312

(21 CFR part 312), which specifies the

information that manufacturers must

submit so that FDA may properly

evaluate the safety and effectiveness of

investigational drugs and biological

products. The information collection

requirements resulting from the

preparation and submission of an IND

under part 312 have been estimated by

FDA and the reporting and

recordkeeping burden has been

approved by OMB until September 30,

2002, under the OMB control number

0910–0014. In the Federal Register of

May 6, 1999 (64 FR 24402), FDA

published a notice requesting comments

on the burden estimates for the

information collection requirements in

part 312. The notice also requested an

extension of OMB approval for this

information collection.

FDA suggests that the cover letter to

the request for special protocol

assessment be submitted via facsimile to

the appropriate division in CDER or

CBER to enable agency staff to prepare

for the arrival of the protocol for

assessment. The agency recommends

that a request for special protocol

assessment be submitted as an

amendment to an IND for two reasons:

(1) To ensure that each request is kept

in the administrative file with the entire

IND, and (2) to ensure that pertinent

information about the request is entered

into the appropriate tracking databases.

Use of the information in the agency’s

tracking databases enables the

appropriate agency official to monitor

progress on the evaluation of the

protocol and to ensure that appropriate

steps will be taken in a timely manner.

CDER and CBER have determined and

the guidance recommends that the

following information should be

submitted to the appropriate Center

with each request for special protocol

assessment so that the Center may

quickly and efficiently respond to the

request:

• Questions to the agency

concerning specific issues regarding the

protocol; and

• All data, assumptions, and

information needed to permit an

adequate evaluation of the protocol,

including: (1) The role of the study in

the overall development of the drug; (2)

information supporting the proposed

trial, including power calculations, the

choice of study endpoints, and other

critical design features; (3) regulatory

outcomes that could be supported by

the results of the study; (4) final labeling

that could be supported by the results

of the study; and (5) for stability

protocol, product characterization and

relevant manufacturing data.

A. Description of Respondents

A sponsor, applicant, or manufacturer

of a drug or biologic product regulated

by the agency under the Federal Food,

Drug, and Cosmetic Act (the act) or

section 351 of the Public Health Service

Act who requests special protocol

assessment.

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