Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices 67385

selection of the applications to be

funded. The Commissioner may also

elect not to fund any applicants having

known management, fiscal, reporting,

program, or other problems which make

it unlikely that they would be able to

provide effective services.

Successful applicants will be notified

through the issuance of a Financial

Assistance Award which will set forth

the amount of funds granted, the terms

and conditions of the grant, the effective

date of the grant, and the budget period

for which initial support will be given.

Organizations whose applications will

not be funded will be notified in writing

by the Commissioner of the

Administration on Children, Youth and

Families. Every effort will be made to

notify all unsuccessful applicants as

soon as possible after final decisions are

made.

Part VII. Application Content and

Submission Instructions

A. Application Content

Each application must contain the

following items in the order listed:

1. Application for Federal Assistance

(Standard Form 424, REV 4–92). Follow

the instructions in the Application Kit.

In Item 8 of Form 424, check ‘‘New.’’ In

Item 10 of the 424, clearly identify the

Catalog of Federal Domestic Assistance

(CFDA) program title and number: Child

Care and Development Block Grant,

93.575.

2. Budget and Budget Justification

(Standard Form 424A, REV 4–92).

Follow the instructions in the

Application Kit. The budget justification

should be typed on standard size plain

white paper, provide breakdowns for

major budget categories and justify

significant costs. List amounts and

sources of all funds, both Federal and

non-Federal, to be used for this project.

3. Project Summary/Abstract (one

page maximum). Clearly mark this page

with the applicant name as shown on

item 5 of the SF 424, identify the title

of the proposed project as shown in

item 11 and the service area as shown

in item 12 of the SF 424. The summary

description should not exceed 300

words.

Care should be taken to produce a

summary which accurately and

concisely reflects the proposed project.

It should describe the objectives of the

project, the approach to be used and the

results and benefits expected.

4. Assurances/Certifications. The

applicant must sign and return a SF

424B, Assurances—non-Construction

Programs form and the Certification

Regarding Lobbying form and return

them with the application. A duly

authorized representative of the

applicant organization must certify that

the applicant is in compliance with

these assurances and certifications.

Note: Although construction is an

allowable cost if approved by ACF (see

Part III, G), the non-construction

assurances are required for purposes of

this application. All requirements

related to construction will be

addressed through the separate

application process for construction and

renovation.

In addition, the applicant must certify

its compliance with: (1) Drug-Free

Workplace Requirements; (2) Debarment

and Other Responsibilities; and (3) ProChildren Act of 1994 (Certification

Regarding Environmental Tobacco

Smoke). A signature on the SF 424

indicates compliance with the Drug Free

Workplace Requirements, Debarment

and Other Responsibilities and

Environmental Tobacco Smoke

Certifications. A signature on the

application constitutes an assurance

that the applicant will comply with the

pertinent Departmental regulations

contained in 45 CFR Part 74.

5. Documents of Support. The

maximum number of pages for

supporting documentation is 10 pages,

double-spaced, exclusive of letters of

support or agreement. These documents

must be numbered and might include

resumes, photocopies of news clippings,

evidence of the program’s efforts to

coordinate child care services at the

local level, etc. Documentation over the

ten-page limit will not be reviewed. The

applicant may, however, include as

many letters of support or agreement as

are appropriate.

B. Application Submission

To be considered for funding, the

applicant must submit one signed

original and two additional copies of the

application, including all attachments,

to the application receipt point

specified above. The original copy of the

application must have original

signatures, signed in black ink. Each

copy must be stapled (back and front) in

the upper left corner. All copies of an

application must be submitted in a

single package.

Because each application will be

duplicated, do not use or include

separate covers, binders, clips, tabs,

plastic inserts, maps, brochures or any

other items that cannot be processed

easily on a photocopy machine with an

automatic feed. Do not bind, clip, staple,

or fasten in any way separate

subsections of the application,

including supporting documentation.

Applicants are advised that the copies

of the application submitted, not the

original, will be reproduced by the

Federal government for review.

(Catalog of Federal Domestic Assistance:

Child Care and Development Block Grant,

93.575)

Dated: November 3, 2000.

James A. Harrell,

Deputy Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 00–28798 Filed 11–08–00; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1033]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Draft

Guidance for Industry on Information

Program on Clinical Trials for Serious

or Life-Threatening Diseases:

Establishment of a Data Bank

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.

DATES: Submit written comments on the

collection of information by December

11, 2000.

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:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In

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

has submitted the following proposed

collection of information to OMB for

review and clearance.

Draft Guidance for Industry on

Information Program on Clinical Trials

for Serious or Life-Threatening

Diseases: Establishment of a Data Bank

In the Federal Register of March 29,

2000 (65 FR 16620), FDA issued a draft

guidance to industry on

67386 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices

recommendations for investigational

new drug application (IND) sponsors on

submitting information about clinical

trials for serious or life-threatening

diseases to a Clinical Trials Data Bank

developed by the National Library of

Medicine, National Institutes of Health

(NIH). This information is especially

important for patients and their families

seeking opportunities to participate in

clinical trials of new drug treatments for

serious or life-threatening diseases. The

draft guidance describes three

collections of information: Mandatory

submissions, voluntary submissions,

and certifications.

I. Mandatory Submissions

Section 113 of the Food and Drug

Administration Modernization Act (the

Modernization Act) (Public Law 105–

115) requires that sponsors shall submit

information to the Clinical Trials Data

Bank when the clinical trial: (1)

Involves a treatment for a serious or lifethreatening disease, and (2) is intended

to assess the effectiveness of the

treatment. The draft guidance discusses

how sponsors can fulfill the

requirements of section 113 of the

Modernization Act. Specifically,

sponsors should provide: (1)

Information about clinical trials, both

federally and privately funded, of

experimental treatments (drugs,

including biological products) for

patients with serious or life-threatening

diseases; (2) a description of the

purpose of the experimental drug; (3)

patient eligibility criteria; (4) the

location of clinical trial sites; and (5) a

point of contact for patients wanting to

enroll in the trial.

II. Voluntary Submissions

Section 113 of the Modernization Act

also specifies that sponsors may

voluntarily submit information

pertaining to results of clinical trials,

including information on potential

toxicities or adverse effects associated

with the use or administration of the

investigational treatment. Sponsors may

also voluntarily submit studies that are

not trials to test effectiveness, or not for

serious or life-threatening diseases, to

the Clinical Trials Data Bank. This

notice of proposed collection only

applies to the voluntary submission of

information pertaining to studies that

are not trials to test effectiveness or not

for serious or life-threatening diseases.

Any paperwork burden associated with

the voluntary submission of information

pertaining to the results of clinical trials

will be discussed in the implementation

document.

III. Certifications

Section 113 of the Modernization Act

specifies that the data bank will not

include information relating to a trial if

the sponsor certifies to the Secretary of

Health and Human Services (the

Secretary) that disclosure of the

information would substantially

interfere with the timely enrollment of

subjects in the investigation, unless the

Secretary makes a determination to the

contrary.

Description of Respondents: A

sponsor of a drug or biologic product

regulated by the agency under the

Federal Food, Drug, and Cosmetic Act

or section 351 of the Public Health

Service Act (42 U.S.C. 262) who submits

a clinical trial to test effectiveness of a

drug or biologic product for a serious or

life-threatening disease.

Burden Estimate: The information

required under section 113(a) of the

Modernization Act is currently

submitted to FDA under 21 CFR part

312, and this collection of information

is approved under OMB Control

Number 0910–0014 until September 30,

2002, and, therefore, does not represent

a new information collection

requirement. Instead, preparation of

submissions under section 113 of the

Modernization Act involves extracting

and reformatting information already

submitted to FDA. Although the

procedures (where and how) for the

actual submission of this information

have not yet been developed, the agency

believes it has an adequate basis for the

determination of the hourly burden

related to extracting and reformatting

this information. The chart below

provides an estimate of the annual

reporting burden for the submission of

information to satisfy requirements of

section 113 of the Modernization Act.

The Center for Drug Evaluation and

Research (CDER) is currently receiving

99.2 new protocols per week (mean

value, March through May 1999), or

5,158 new protocols per year. CDER

anticipates that protocol submission

rates will remain at or near this level in

the near future. Of these new protocols,

an estimated two-thirds are for serious

or life-threatening diseases and would

be subject to either voluntary or

mandatory reporting requirements

under section 113 of the Modernization

Act. Two-thirds of 5,158 protocols per

year is 3,439 new protocols per year. An

estimated 65 percent of the new

protocols for serious or life-threatening

diseases submitted to CDER are for

clinical trials involving assessment for

effectiveness, and are subject to the

mandatory reporting requirements

under section 113 of the Modernization

Act. Sixty-five percent of 3,439

protocols per year is 2,235 new

protocols per year subject to mandatory

reporting. The remaining 2,923 new

protocols per year are subject to

voluntary reporting.

The Center for Biologics Evaluation

and Research (CBER) is currently

receiving 29 new protocols per month,

or 348 new protocols per year. CBER

anticipates that protocol submission

rates will remain at or near this level in

the near future. An estimated two-thirds

of the new protocols submitted to CBER

are for clinical trials involving a serious

or life-threatening disease, and would

be subject to either voluntary or

mandatory reporting requirements

under section 113 of the Modernization

Act. Two-thirds of 348 new protocols

per year is 232 new protocols per year.

An estimated 65 percent of the new

protocols for serious or life-threatening

diseases submitted to CBER are for

clinical trials involving assessments for

effectiveness. Sixty-five percent of 232

protocols per year is an estimated 151

new protocols per year subject to the

mandatory reporting requirements

under section 113 of the Modernization

Act. The remaining 197 new protocols

per year are subject to voluntary

reporting.

The estimated total number of new

protocols for serious or life-threatening

diseases subject to mandatory reporting

requirements under section 113 of the

Modernization Act is 2,235 for CDER

plus 151 for CBER, or 2,386 new

protocols per year. The remainder of

protocols submitted to CDER or CBER

will be subject to voluntary reporting,

including clinical trials not involving a

serious or life-threatening disease as

well as trials in a serious or lifethreatening disease but not involving

assessment of effectiveness. Therefore,

the total number of protocols (5,506)

minus the protocols subject to

mandatory reporting requirements

(2,386) will be subject to voluntary

reporting, or 3,120 protocols.

It was originally estimated that the

protocol submissions to the data bank

will be updated 2.5 times per year under

section 113 of the Modernization Act. In

the Federal Register of March 29, 2000,

the agency requested comments on the

proposed collection of information. One

comment was received. The comments

stated that FDA greatly underestimated

the burden by excluding multicenter

studies and not accounting for the

quality control review of the data before

it is submitted to the data bank. We

estimated that 5,506 new protocols are

submitted each year and each new

protocol is updated 2.5 times per year

with information that would necessitate

Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices 67387

a change in the data bank. We further

estimated that each change requires an

average of 5.6 hours resulting in 77,084

hours spent by respondents per year.

These estimates included protocols

subject to mandatory and voluntary

reporting requirements.

For the revised justification, we

reviewed actual IND data from 1997 to

1999, and as a result of our reanalysis

we incorporated new estimates that

consider multicenter studies. The

average number of IND amendments

submitted annually for protocol changes

(e.g., changes in eligibility criteria) was

4,019 for CDER and 1,441 for CBER. The

average number of IND amendments

submitted annually for new

investigators was 7,745 for CDER and

1,349 for CBER. The number of protocol

changes and new investigators was

apportioned proportionally between

mandatory and voluntary submissions.

We recognize that single submissions

may include information about multiple

sites.

Generally, there is no submission to

FDA when an individual study site is no

longer recruiting study subjects. For this

analysis, we assumed that the number of

study sites closed each year is similar to

the number of new investigator

amendments received by FDA (7,745

CDER and 1,349 CBER).

Generally, there is no submission to

FDA when the study is closed to

enrollment. We estimate the number of

protocols closed to enrollment each year

is similar to the number of new

protocols submitted (5,158 CDER and

348 CBER).

The hours per response is the

estimated number of hours that a

respondent would spend preparing the

information to be submitted under

section 113(a) of the Modernization Act,

including the time it takes to extract and

reformat the information. FDA has been

advised that some sponsors lack

information system capabilities enabling

efficient collection of company-wide

information on clinical trials subject to

reporting requirements under section

113(a) of the Modernization Act. The

estimation of burden under section

113(a) reflects the relative inefficiency

of this process for these firms.

Based on its experience reviewing

IND’s, and consideration of the above

information, FDA estimated that

approximately 5.6 hours on average

would be needed per response (mean

value), based on an estimated 3.2 hours

for data extraction and 2.4 hours for

reformatting. We considered quality

control issues when developing the

original burden estimates of 3.2 hours

for data extraction and the 2.4 hours

estimated for reformatting. Additionally,

the data entry system being developed

incorporates features that will further

decrease the sponsor’s time

requirements for quality control

procedures. No new estimates for

quality control are included in the

reanalysis.

The new estimate continues to use an

average of 5.6 hours per response for

calculations related to new submissions.

Changes related to the addition and

deletion of investigational sites will

involve minimal resource commitments

from the sponsor. Further, many

protocol changes will not require

changes to the data bank. Other protocol

changes will require minimal time to

make changes to the data bank (e.g.,

modification of eligibility criteria). The

5.6 hours per response estimate for

these types of responses is high.

A sponsor of a study subject to the

requirements of section 113 of the

Modernization Act will have the option

of submitting data under that section or

certifying to the Secretary that

disclosure of information for a specific

protocol would substantially interfere

with the timely enrollment of subjects

in the clinical investigation. FDA has no

means to accurately predict the

proportion of protocols subject to the

requirements of section 113 of the

Modernization Act that will be subject

to a certification submission. However,

it is anticipated that the burden

associated with such certification will

be comparable to that associated with

submission of data regarding a protocol.

Therefore, the overall burden is

anticipated to be the same, regardless of

whether the sponsor chooses data

submission or certification for

nonsubmission. The table below reflects

the estimate of this total burden.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

New

Protocols

Recruitment

Complete

Protocol

Changes

New

Investigators

Sites

Closed

Total

Responses

Hours per

Response Total Hours

CDER (mandatory) .......... 2,235 2,235 1,728 3,330 3,330 12,858 5.6 72,005

CBER (mandatory) ........... 151 151 620 580 580 2,082 5.6 11,659

CDER (voluntary) ............. 2,923 2,923 2,291 4,415 4,415 16,967 5.6 95,015

CBER (voluntary) ............. 197 197 821 769 769 2,753 5.6 15,417

Total ................................. 194,096

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

The revised burden estimate for

responses (34,660) is 2.5 times the

original estimate (13,765).

We believe that the original burden

estimate of 77,084 hours spent per year

underestimated the burden. The new

estimate, 194,096 hours per year (34,660

responses x 5.6 hours per response),

more accurately reflects the burden.

NIH and FDA are considering a pilot

program for the electronic submission of

protocol information over the Internet.

The purpose of the pilot project is

twofold. First, the pilot project will

allow FDA to test its systems for

receiving electronic submissions under

section 113 of the Modernization Act.

Second, the pilot project will provide

opportunities for volunteers to gain

experience in using the prototype

system that will enable them to provide

technical feedback on how well the

system is working, and also to offer

suggestions for change. The experience

gained from this pilot project also will

facilitate the development of the

implementation plan.

FDA anticipates that up to 25

sponsors will volunteer to participate in

a pilot program involving the electronic

submission of protocol information over

the Internet. Protocol information

entered into the system during the pilot

project will be included in the Clinical

Trials Data Bank (ClinicalTrials.gov).

We estimate that each sponsor will

include 10 protocols in the data bank.

We estimate that each protocol will be

modified two times and add three new

sites. It is assumed that the sites will

remain open for the duration of the

pilot. The one-time burden estimate for

the pilot program is 8,400 (1,500

responses x 5.6 hours/response). Since

67388 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices

the pilot protocols will be included in

the ClinicalTrials.gov data bank, the

estimated annual burden for the first

year will be reduced by the number of

protocols included in the pilot.

FDA estimates the burden of the

collection of information as follows:

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN 1

New Protocols Protocol

Changes

New

Investigators

Total Annual

Responses

Hours per

Response Total Hours

CDER 200 400 600 1,200 5.6 6,720

CBER 50 100 150 300 5.6 1,680

Total 8,400

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

Dated: November 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28851 Filed 11–8–00; 8:45 am]

BILLING CODE 4160–01–F /

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1441]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Infant

Formula Requirements

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.

DATES: Submit written comments on the

collection of information by December

11, 2000.

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:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

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

has submitted the following proposed

collection of information to OMB for

review and clearance.

Infant Formula Requirements (OMB

Control Number 0910–0256)—Extension

Statutory requirements for infant

formula under the Federal Food, Drug,

and Cosmetic Act (the act) are intended

to protect the health of infants and

include a number of reporting and

recordkeeping requirements. Among

other things, section 412 of the act (21

U.S.C. 350a) requires manufacturers of

infant formula to: (1) Establish and

adhere to quality control procedures, (2)

notify FDA when a batch of infant

formula that has left the manufacturers’

control may be adulterated or

misbranded, and (3) keep records of

distribution. FDA has issued regulations

to implement the act’s requirements for

infant formula in parts 106 and 107 (21

CFR parts 106 and 107). FDA also

regulates the labeling of infant formula

under the authority of section 403 of the

act (21 U.S.C. 343). Under the labeling

regulations for infant formula in part

107, the label of an infant formula must

include nutrient information and

directions for use. The purpose of these

labeling requirements is to ensure that

consumers have the information they

need to prepare and use infant formula

appropriately. In a document published

in the Federal Register of July 9, 1996

(61 FR 36154), FDA proposed changes

in the infant formula regulations,

including some of those listed in tables

1 and 2 of this document. The document

included revised burden estimates for

the proposed changes and solicited

public comment. In the interim,

however, FDA is seeking an extension of

OMB approval for the current

regulations so that it can continue to

collect information while the proposal

is pending.

In the Federal Register of August 18,

2000 (65 FR 50539), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Federal Food, Drug, and Cosmetic Act (the Act) or

21 CFR Section

No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Section 412(d) of the act 4 7 28 10 280

106.120(b) 4 0.25 1 4 4

107.10(a) and 107.20 4 7 28 8 224

107.50(b)(3) and (b)(4) 3 4 12 4 48

107.50(e)(2) 3 0.33 1 4 4

Total 560

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