Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices 29143

submission for selected devices. After

reviewing a submission, the reviewer

will forward a copy of the 510(k)

submission, along with the reviewer’s

documented review and

recommendation, to FDA. Third-party

reviews should maintain records of their

510(k) reviews and a copy of the 510(k)

for a reasonable period of time. This

information collection will allow FDA

to continue to implement the accredited

person review program established by

FDAMA and improve the efficiency of

510(k) review for low to moderate risk

devices.

Respondents to this information

collection are businesses or other forprofit organizations.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Item No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Requests for accreditation ........................................ 40 1 40 24 960

510(k) reviews conducted by accredited third parties .......................................................................... 35 4 140 40 5,600

Total ....................................................................... 6,560

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Item No. of

Recordkeepers

Annual Frequency

per Recordkeeper

Total Annual

Records

Hours per

Recordkeeper Total Hours

510(k) reviews ................... 35 4 140 10 1,400

Total ............................... 1,400

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

The burdens are explained as follows:

1. Reporting

a. Requests for accreditation. Under

the agency’s third-party review pilot

program, the agency received 37

applications for recognition as thirdparty reviewers, of which the agency

recognized 7. Under this expanded

program, the agency anticipates that it

will not see a significant increase in the

number of applicants. Therefore, the

agency is estimating that it will receive

40 applications. The agency anticipates

that it will accredit 35 of the applicants

to conduct third-party reviews.

b. 510(k) reviews conducted by

accredited third parties. In the 18

months under the third-party review

pilot program, FDA received only 22

510(k)s that requested and were eligible

for review by third parties. Because the

third-party review program is not as

limited in time, and is expanded in

scope, the agency anticipates that the

number of 510(k)s submitted for thirdparty review will remain the same as

they were during the last OMB approval

in 1998. The agency anticipates that it

will receive approximately 140 thirdparty review submissions annually, i.e.,

approximately 4 annual reviews per

each of the estimated 35 accredited

reviewers.

2. Recordkeeping

Third-party reviewers are required to

keep records of their review of each

submission. The agency anticipates

approximately 140 annual submissions

of 510(k)s for third-party review.

The estimate of the times required for

record preparation and maintenance is

based on agency communication with

industry. Other information needed to

calculate the total burden hours (i.e.,

adverse drug reaction, lack of

effectiveness, and product defect

reports) are derived from agency records

and experience.

Dated: May 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13301 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0205]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Applications for

FDA Approval to Market a New Drug

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

requirements governing applications for

FDA approval to market a new drug.

DATES: Submit written or electronic

comments on the collection of

information by July 30, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

All comments should be identified with

the docket number found in brackets in

the heading of this document.

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: Under the

PRA (44 U.S.C. 3501-3520), Federal

agencies must obtain approval from the

Office of Management and Budget

29144 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Applications for FDA Approval to

Market a New Drug—21 CFR Part 314

(OMB Control Number 0910–0001)—

Extension

Under section 505(a) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 355(a)), a new drug may not

be commercially marketed in the United

States, imported, or exported from the

United States, unless an approval of an

application filed with FDA under

section 505(b) or (j) of the act is effective

with respect to such drug. Section

505(b) and (j) of the act requires a

sponsor to submit to FDA a new drug

application (NDA) containing, among

other things, full reports of

investigations that show whether or not

the drug is safe and effective for use, a

full list of articles used as components

in the drug, a full description of

manufacturing methods, samples of the

drugs required, specimens of the

labeling proposed to be used, and

certain patent information as applicable.

Under the act, it is the sponsor’s

responsibility to provide the

information needed by FDA to make a

scientific and technical determination

that the product is safe and effective.

This information collection approval

request is for all information

requirements imposed on sponsors by

the regulations under part 314 (21 CFR

part 314), who apply for approval of a

NDA in order to market or to continue

to market a drug.

Section 314.50(a) requires that an

application form (Form FDA 356h) be

submitted that includes introductory

information about the drug as well as a

checklist of enclosures.

Section 314.50(b) requires that an

index be submitted with the archival

copy of the application and that it

reference certain sections of the

application.

Section 314.50(c) requires that a

summary of the application be

submitted that presents a good general

synopsis of all the technical sections

and other information in the

application.

Section 314.50(d) requires that the

NDA contain the following technical

sections about the new drug: Chemistry,

manufacturing, and controls;

nonclinical pharmacology and

toxicology; human pharmacokinetics

and bioavailability; microbiology;

clinical data; and statistical section.

Section 314.50(e) requires the

applicant to submit samples of the drug

if requested by FDA. In addition, the

archival copy of the application must

include copies of the label and all

labeling for the drug.

Section 314.50(f) requires that case

report forms and tabulations be

submitted with the archival copy.

Section 314.50(h) requires that patent

information, as described under

§ 314.53, be submitted with the

application.

Section 314.50(i) requires that patent

certification information be submitted

in section 505(b)(2) of the act

applications for patents claiming the

drug, drug product, method of use, or

method of manufacturing.

Section 314.50(j) requires that

applicants that request a period of

marketing exclusivity submit certain

information with the application.

Section 314.50(k) requires that an

archival, review, and field copy of the

application be submitted.

Section 314.52 requires that notice of

certification of invalidity or

noninfringement of a patent to patent

holders and NDA holders be sent by

section 505(b)(2) of the act applicants.

Section 314.54 sets forth the content

requirements for applications filed

under section 505(b)(2) of the act.

Section 314.60 sets forth reporting

requirements for sponsors who amend

an unapproved application.

Section 314.65 states that the sponsor

must notify FDA when withdrawing an

unapproved application.

Sections 314.70 and 314.71 require

that supplements be submitted to FDA

for certain changes to an approved

application.

Section 314.72 requires sponsors to

report to FDA any transfer of ownership

of an application.

Section 314.80(c)(1) and (c)(2) sets

forth requirements for expedited

adverse drug experience postmarketing

reports and followup reports, as well as

for periodic adverse drug experience

postmarketing reports (Form FDA

3500A). (The burden hours for

§ 314.80(c)(1) and (c)(2) are already

approved by OMB under 0910–0230 and

0910–0291 and are not included in the

hour burden estimates in table 1 of this

document).

Section 314.80(i) establishes

recordkeeping requirements for reports

of postmarketing adverse drug

experiences. (The burden hours for

§ 314.80(i) are already approved by

OMB under 0910–0230 and 0910–0291

and are not included in the hour burden

estimates in table 1 of this document).

Section 314.81(b)(1) requires that field

alert reports be submitted to FDA (Form

FDA 3331).

Section 314.81(b)(2) requires that

annual reports be submitted to FDA

(Form FDA 2252).

Section 314.81(b)(3)(i) requires that

drug advertisements and promotional

labeling be submitted to FDA (Form

FDA 2253).

Section 314.81(b)(3)(iii) sets forth

reporting requirements for sponsors

who withdraw an approved drug

product from sale. (The burden hours

for § 314.81(b)(3)(iii) are already

approved by OMB under 0910–0045 and

are not included in the hour burden

estimates in table 1 of this document).

Section 314.90 sets forth requirements

for sponsors who request waivers from

FDA for compliance with §§ 314.50

through 314.81. (The information

collection hour burden estimate for

NDA waiver requests is included in

table 1 of this document under estimates

for §§ 314.50, 314.60, 314.70, and

314.71).

Section 314.93 sets forth requirements

for submitting a suitability petition in

accordance with 21 CFR 10.20 and

10.30. (The burden hours for § 314.93

are already approved by OMB under

0910–0183 and are not included in the

hour burden estimates in table 1 of this

document).

Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices 29145

Section 314.94(a) and (d) requires that

an abbreviated new drug application

(ANDA) contain the following

information: Application form; table of

contents; basis for ANDA submission;

conditions of use; active ingredients;

route of administration, dosage form,

and strength; bioequivalence; labeling;

chemistry, manufacturing, and controls;

samples; patent certification.

Section 314.95 requires that notice of

certification of invalidity or

noninfringement of a patent to patent

holders and NDA holders be sent by

ANDA applicants.

Section 314.96 sets forth requirements

for amendments to an unapproved

ANDA.

Section 314.97 sets forth requirements

for submitting supplements to an

approved ANDA for changes that

require FDA approval.

Section 314.98(a) sets forth

postmarketing adverse drug experience

reporting and recordkeeping

requirements for ANDAs. (The burden

hours for § 314.98(a) are already

approved by OMB under 0910–0230 and

0910–0291 and are not included in the

hour burden estimates in table 1 of this

document).

Section 314.98(c) requires other

postmarketing reports for ANDAs: Field

alert reports (Form FDA 3331), annual

reports (Form FDA 2252), and

advertisements and promotional

labeling (Form FDA 2253). (The

information collection hour burden

estimate for field alert reports is

included in table 1 of this document

under § 314.81(b)(1); the estimate for

annual reports is included under

§ 314.81(b)(2); the estimate for

advertisements and promotional

labeling is included under

§ 314.81(b)(3)(i)).

Section 314.99(a) requires that

sponsors comply with certain reporting

requirements for withdrawing an

unapproved ANDA and for a change in

ownership of an ANDA.

Section 314.99(b) sets forth

requirements for sponsors who request

waivers from FDA for compliance with

§§ 314.92 through 314.99. (The

information collection hour burden

estimate for ANDA waiver requests is

included in table 1 of this document

under estimates for §§ 314.94(a) and (d),

314.96, and 314.97).

Section 314.101(a) states that if FDA

refuses to file an application, the

applicant may request an informal

conference with FDA and request that

the application be filed over protest.

Section 314.107(c)(4) requires notice

to FDA by ANDA or section 505(b)(2) of

the act application holders of any legal

action concerning patent infringement.

Section 314.107(e)(2)(iv) requires that

an applicant submit a copy of the entry

of the order or judgment to FDA within

10 working days of a final judgment.

Section 314.107(f) requires that

ANDA or section 505(b)(2) of the act

applicants notify FDA of the filing of

any legal action filed within 45 days of

receipt of the notice of certification. A

patent owner may also notify FDA of the

filing of any legal action for patent

infringement. The patent owner or

approved application holder who is an

exclusive patent licensee must submit to

FDA a waiver that waives the

opportunity to file a legal action for

patent infringement.

Section 314.110(a)(3) and (a)(4) states

that, after receipt of an FDA approvable

letter, an applicant may request an

opportunity for a hearing on the

question of whether there are grounds

for denying approval of the application.

(The burden hours for § 314.110(a)(3)

and (a)(4) are included under the parts

10 through 16 (21 CFR part 10 through

16) hearing regulations, in accordance

with § 314.201, and are not included in

the hour burden estimates in table 1 of

this document).

Section 314.110(a)(5) states that, after

receipt of an approvable letter, an

applicant may notify FDA that it agrees

to an extension of the review period so

that it can determine whether to

respond further.

Section 314.110(b) states that, after

receipt of an approvable letter, an

ANDA applicant may request an

opportunity for a hearing on the

question of whether there are grounds

for denying approval of the application.

(The burden hours for § 314.110(b) are

included under the parts 10 through 16

hearing regulations, in accordance with

§ 314.201, and are not included in the

hour burden estimates in table 1 of this

document).

Section 314.120(a)(3) states that, after

receipt of a not approvable letter, an

applicant may request an opportunity

for a hearing on the question of whether

there are grounds for denying approval

of the application. (The burden hours

for § 314.120(a)(3) are included under

the parts 10 through 16 hearing

regulations, in accordance with

§ 314.201, and are not included in the

hour burden estimates in table 1 of this

document).

Section 314.120(a)(5) states that, after

receipt of a not approvable letter, an

applicant may notify FDA that it agrees

to an extension of the review period so

that it can determine whether to

respond further.

Section 314.122(a) requires that an

ANDA or a suitability petition that

relies on a listed drug that has been

voluntarily withdrawn from sale must

be accompanied by a petition seeking a

determination whether the drug was

withdrawn for safety or effectiveness

reasons. (The burden hours for

§ 314.122(a) are already approved by

OMB under 0910–0183 and are not

included in the hour burden estimates

in table 1 of this document).

Section 314.122(d) sets forth

requirements for relisting petitions for

unlisted discontinued products. (The

burden hours for § 314.122(d) are

already approved by OMB under 0910–

0183 and are not included in the hour

burden estimates in table 1 of this

document).

Section 314.126(c) sets forth

requirements for a petition to waive

criteria for adequate and well-controlled

studies. (The burden hours for

§ 314.126(c) are already approved by

OMB under 0910–0183 and are not

included in the hour burden estimates

in table 1 of this document).

Section 314.151(a) and (b) sets forth

requirements for the withdrawal of

approval of an ANDA and the

applicant’s opportunity for a hearing

and submission of comments. (The

burden hours for § 314.151(a) and (b) are

included under the parts 10 through 16

hearing regulations, in accordance with

§ 314.201, and are not included in the

hour burden estimates in table 1 of this

document).

Section 314.151(c) sets forth the

requirements for withdrawal of approval

of an ANDA and the applicant’s

opportunity to submit written objections

and participate in a limited oral hearing.

(The burden hours for § 314.151(c) are

included under the parts 10 through 16

hearing regulations, in accordance with

§ 314.201, and are not included in the

hour burden estimates in table 1 of this

document).

Section 314.152(b) sets forth the

requirements for suspension of an

ANDA when the listed drug is

voluntarily withdrawn for safety and

effectiveness reasons, and the

applicant’s opportunity to present

comments and participate in a limited

oral hearing. (The burden hours for

§ 314.152(b) is included under the parts

10 through 16 hearing regulations, in

accordance with § 314.201, and is not

included in the hour burden estimates

in table 1 of this document).

Section 314.161(b) and (e) sets forth

the requirements for submitting a

petition to determine whether a listed

drug was voluntarily withdrawn from

sale for safety or effectiveness reasons.

(The burden hours for § 314.161(b) and

(e) are already approved by OMB under

0910–0183 and are not included in the

29146 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices

hour burden estimates in table 1 of this

document).

Section 314.200(c), (d), and (e)

requires that applicants or others subject

to a notice of opportunity for a hearing

who wish to participate in a hearing file

a written notice of participation and

request for a hearing as well as the

studies, data, and so forth, relied on.

Other interested persons may also

submit comments on the notice. This

section also sets forth the content and

format requirements for the applicants’

submission in response to notice of

opportunity for hearing. (The burden

hours for § 314.200(c), (d), and (e) are

included under the parts 10 through 16

hearing regulations, in accordance with

§ 314.201, and are not included in the

hour burden estimates in table 1 of this

document).

Section 314.200(f) states that

participants in a hearing may make a

motion to the presiding officer for the

inclusion of certain issues in the

hearing. (The burden hours for

§ 314.200(f) are included under the parts

10 through 16 hearing regulations, in

accordance with § 314.201, and are not

included in the hour burden estimates

in table 1 of this document).

Section 314.200(g) states that a person

who responds to a proposed order from

FDA denying a request for a hearing

provide sufficient data, information, and

analysis to demonstrate that there is a

genuine and substantial issue of fact

that justifies a hearing. (The burden

hours for § 314.200(g) are included

under the parts 10 through 16 hearing

regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in table 1 of this

document.)

Section 314.420 states that an

applicant may submit to FDA a drug

master file in support of an application,

in accordance with certain content and

format requirements.

Section 21 CFR 314.430 states that

data and information in an application

are disclosable under certain conditions,

unless the applicant shows that

extraordinary circumstances exist. (The

burden hours for § 314.530 is included

under the parts 10 through 16 hearing

regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in table 1 of this

document).

Section 314.530(c) and (e) states that,

if FDA withdraws approval of a drug

approved under the accelerated

approval procedures, the applicant has

the opportunity to request a hearing and

submit data and information. (The

burden hours for § 314.530(c) and (e) are

included under the parts 10 through 16

hearing regulations, in accordance with

§ 314.201, and are not included in the

hour burden estimates in table 1 of this

document).

Section 314.530(f) requires that an

applicant first submit a petition for stay

of action before requesting an order

from a court for a stay of action pending

review. (The burden hours for

§ 314.530(f) are already approved by

OMB under 0910–0194 and are not

included in the hour burden estimates

in table 1 of this document).

Respondents to this collection of

information are all persons who submit

an application or abbreviated

application or an amendment or

supplement to FDA under part 314 to

obtain approval of a new drug, and any

person who owns an approved

application or abbreviated application.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section; [Form

Number] No. of Respondents No. of Responsesper Respondent

Total Annual Responses Hours per Response Total Hours

314.50(a), (b), (c), (d), (e),

(f), (h), and (k) 71 1.55 110 1,666 183,260

314.50() and 314.94(a)(12) 97 3.4 331 2 662

314.50(j) 92 2.7 250 2 500

314.52 and 314.95 37 2 75 16 1,200

314.54 11 1 11 300 3,300

314.60 125 19.92 2,490 80 199,200

314.65 29 1.24 36 2 72

314.70 and 314.71 204 11.54 2,354 300 706,200

314.72 70 2.90 205 2 410

314.81(b)(1) [3331] 82 3.43 281 8 2,248

314.81(b)(2) [2252] 600 12.66 7,597 40 303,880

314.81(b)(3)() [2253] 196 2.42 475 2 950

314.94(a) and (d) 125 2.92 365 480 175,200

314.96 225 7.25 1,631 80 130,480

314.97 175 17.44 3,052 80 244,160

314.99(a) 45 8.88 400 2 800

314.101(a) 6 1 6 .50 3

314.107(c)(4), (e)(2)(v),

and (f) 34 2 71 1 71

314.110(a)(5) 50 1.66 83 .50 41.5

314.120(a)(5) 22 1.04 23 .50 11.5

314.420 462 1.1 514 61 31,354

Total 1,984,003

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

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.