Reducing Regulatory Burden

This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules

Federal Register

43347

Vol. 69, No. 138

Tuesday, July 20, 2004

DEPARTMENT OF THE TREASURY

Office of the Comptroller of the

Currency

12 CFR Chap. I

[Docket No. 04–18]

BOARD OF GOVERNORS OF THE

FEDERAL RESERVE SYSTEM

12 CFR Chap. II

[Docket No. R–1206]

FEDERAL DEPOSIT INSURANCE

CORPORATION

12 CFR Chap. III

DEPARTMENT OF THE TREASURY

Office of Thrift Supervision

12 CFR Chap. V

[No. 2004–35]

Request for Burden Reduction

Recommendations; Consumer

Protection: Account/Deposit

Relationships and Miscellaneous

Consumer Rules; Economic Growth

and Regulatory Paperwork Reduction

Act of 1996 Review

AGENCIES: Office of the Comptroller of

the Currency (OCC), Treasury; Board of

Governors of the Federal Reserve

System (Board); Federal Deposit

Insurance Corporation (FDIC); and

Office of Thrift Supervision (OTS),

Treasury.

ACTION: Notice of regulatory review;

request for comments.

SUMMARY: The OCC, Board, FDIC, and

OTS (‘‘we’’ or ‘‘the Agencies’’) are

reviewing our regulations to identify

outdated, unnecessary, or unduly

burdensome regulatory requirements

pursuant to the Economic Growth and

Regulatory Paperwork Reduction Act of

1996 (EGRPRA). Today, we request your

comments and suggestions on ways to

reduce burden in rules we have

categorized as Consumer Protection:

Account/Deposit Relationships and

Miscellaneous Consumer Rules,

consistent with our statutory

obligations. All comments are welcome

unduly

burdensome regulatory requirements

pursuant to the Economic Growth and

Regulatory Paperwork Reduction Act of

1996 (EGRPRA). Today, we request your

comments and suggestions on ways to

reduce burden in rules we have

categorized as Consumer Protection:

Account/Deposit Relationships and

Miscellaneous Consumer Rules,

consistent with our statutory

obligations. All comments are welcome.

We specifically invite comment on the

following issues: Whether statutory

changes are needed; whether the

regulations contain requirements that

are not needed to serve the purposes of

the statutes they implement; the extent

to which the regulations may adversely

affect competition; the cost of

compliance associated with reporting,

recordkeeping, and disclosure

requirements, particularly on small

institutions; whether any regulatory

requirements are inconsistent or

redundant; and whether any regulations

are unclear.

We will analyze the comments

received and propose burden-reducing

changes to our regulations where

appropriate. Some of your suggestions

for burden reduction might require

legislative changes. Where legislative

changes would be required, we will

consider your suggestions in

recommending appropriate changes to

Congress.

DATES: Written comments must be

received no later than October 18, 2004.

ADDRESSES: You may submit comments

by any of the following methods:

EGRPRA Web site: http://

www.EGRPRA.gov.

• Comments submitted at the

Agencies’ joint Web site will

automatically be distributed to all the

Agencies upon receipt. Comments

received at the EGRPRA Web site and by

other means will be posted on the Web

site to the extent possible

st be

received no later than October 18, 2004.

ADDRESSES: You may submit comments

by any of the following methods:

EGRPRA Web site: http://

www.EGRPRA.gov.

• Comments submitted at the

Agencies’ joint Web site will

automatically be distributed to all the

Agencies upon receipt. Comments

received at the EGRPRA Web site and by

other means will be posted on the Web

site to the extent possible.

Individual agency addresses: You are

also welcome to submit comments to

the Agencies at the following contact

points (due to delays in paper mail

delivery in the Washington area,

commenters may prefer to submit their

comments by alternative means):

OCC: You may submit comments,

identified by [docket 0418], by any of

the following methods:

• E-mail:

regs.comments@occ.treas.gov. Include

[docket 0418] in the subject line of the

message.

• Fax: (202) 874–4448.

• Mail: Public Information Room,

Office of the Comptroller of the

Currency,250 E Street, SW., Mailstop 1–

5,Washington, DC 20219,Attention:

Docket ##.

Public Inspection: You may inspect

and photocopy comments at the Public

Information Room. You can make an

appointment to inspect the comments

by calling (202) 874–5043.

Board: You may submit comments,

identified by Docket Number R–1206,

by any of the following methods:

• Agency Web site: http://

www.federalreserve.gov. Follow the

instructions for submitting comments at

http://www.federalreserve.gov/

generalinfo/foia/ProposedRegs.cfm.

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the

instructions for submitting comments.

• E-mail:

regs.comments@federalreserve.gov.

Include docket number in the subject

line of the message.

• Fax: (202) 452–3819 or (202) 452–

3102.

• Mail: Jennifer J. Johnson, Secretary,

Board of Governors of the Federal

Reserve System,20th Street and

Constitution Avenue, NW.,Washington,

DC 20551

lemaking Portal: http://

www.regulations.gov. Follow the

instructions for submitting comments.

• E-mail:

regs.comments@federalreserve.gov.

Include docket number in the subject

line of the message.

• Fax: (202) 452–3819 or (202) 452–

3102.

• Mail: Jennifer J. Johnson, Secretary,

Board of Governors of the Federal

Reserve System,20th Street and

Constitution Avenue, NW.,Washington,

DC 20551.

All public comments are available

from the Board’s Web site at

www.federalreserve.gov/generalinfo/

foia/ProposedRegs.cfm as submitted,

except as necessary for technical

reasons. Accordingly, your comments

will not be edited to remove any

identifying or contact information.

Public comments may also be viewed

electronically or in paper in Room MP–

500 of the Board’s Martin Building (20th

and C Streets, NW.) between 9 a.m. and

5 p.m. on weekdays.

FDIC: You may submit comments,

identified as EGRPRA burden reduction

comments, by any of the following

methods:

• http://www.fdic.gov/regulations/

laws/federal/propose.html.

• E-mail: comments@fdic.gov.

Include ‘‘EGRPRA burden reduction

comment’’ in the subject line of the

message.

• Mail: Robert E. Feldman, Executive

Secretary, Federal Deposit Insurance

Corporation,550 17th Street,

NW.,Washington, DC 20429.

• Hand Delivery: Comments may be

hand delivered to the guard station at

the rear of the 550 17th Street Building

(located on F Street) on business days

between 7 a.m. and 5 p.m.

Public Inspection: You may inspect

comments at the FDIC Public

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Street,

NW.,Washington, DC 20429.

• Hand Delivery: Comments may be

hand delivered to the guard station at

the rear of the 550 17th Street Building

(located on F Street) on business days

between 7 a.m. and 5 p.m.

Public Inspection: You may inspect

comments at the FDIC Public

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Federal Register / Vol. 69, No. 138 / Tuesday, July 20, 2004 / Proposed Rules

1 The National Credit Union Administration has

participated in planning the EGRPRA review but

has issued, and will issue, requests for comment

separately.

2 Public Law 104–208, Sept. 30, 1996, 12 U.S.C.

3311. We published our first notice in the Federal

Register on June 16, 2003, at 68 FR 35589. We

published our second notice on January 21, 2004,

at 69 FR 2852. You may view the notices at our Web

site: http://www.EGRPRA.gov.

Information Center, Room 100, 801 17th

Street, NW., between 9 a.m. and 4:30

p.m. on business days.

OTS: You may submit comments,

identified by ‘‘No. 2004–35.’’ by any of

the following methods:

• E-Mail:

regs.comments@ots.treas.gov. Include

‘‘No. 2004–35’’ in the subject line of the

message, and provide your name and

telephone number.

• Fax: (202) 906–6518.

• Mail: Regulation Comments, Chief

Counsel’s Office, Office of Thrift

Supervision,1700 G Street,

NW.,Washington, DC 20552.

• Hand Delivery: Comments may be

hand delivered to the Guard’s Desk, East

Lobby Entrance, 1700 G Street, NW.,

from 9 a.m. to 4 p.m. on business days,

Attention: Regulation Comments, Chief

Counsel’s Office.

Public Inspection: OTS will post

comments and the related index on the

OTS Internet site at http://

www.ots.treas.gov. In addition, you may

inspect comments at the Public Reading

Room, 1700 G Street, NW., by

appointment. To make an appointment

for access, call (202) 906–5922, send an

e-mail to public.info@ots.treas.gov, or

send a fax to (202) 906–7755

on Comments, Chief

Counsel’s Office.

Public Inspection: OTS will post

comments and the related index on the

OTS Internet site at http://

www.ots.treas.gov. In addition, you may

inspect comments at the Public Reading

Room, 1700 G Street, NW., by

appointment. To make an appointment

for access, call (202) 906–5922, send an

e-mail to public.info@ots.treas.gov, or

send a fax to (202) 906–7755. (Please

identify the material you would like to

inspect to assist us in serving you.)

FOR FURTHER INFORMATION CONTACT:

OCC:

• Stuart Feldstein, Assistant Director,

Legislative and Regulatory Activities

Division, (202) 874–5090.

• Heidi Thomas, Special Counsel,

Legislative and Regulatory Activities

Division, (202) 874–5090.

• Lee Walzer, Counsel, Legislative

and Regulatory Activities Division,

(202) 874–5090.

Board:

• Patricia A. Robinson, Managing

Senior Counsel, Legal Division, (202)

452–3005.

• Michael J. O’Rourke, Counsel, Legal

Division, (202) 452–3288.

• John C. Wood, Counsel, Division of

Consumer and Community Affairs, (202)

452–2412.

• Arleen Lustig, Supervisory

Financial Analyst, Division of Banking

Supervision and Regulation, (202) 452–

5259.

• For users of Telecommunications

Device for the Deaf (TDD) only, contact

(202) 263–4869.

FDIC:

• Claude A. Rollin, Special Assistant

to the Vice Chairman, (202) 898–8741.

• Steven D. Fritts, Associate Director,

Division of Supervision and Consumer

Protection, (202) 898–3723.

• Ruth R. Amberg, Senior Counsel,

Legal Division, (202) 898–3736.

• Thomas Nixon, Counsel, Legal

Division, (202) 898–8766.

OTS:

• Robyn Dennis, Manager, Thrift

Policy, Supervision Policy, (202) 906–

5751.

• Josephine Battle, Program Analyst,

Thrift Policy, Supervision Policy, (202)

906–6870.

• Karen Osterloh, Special Counsel,

Regulations and Legislation Division,

Chief Counsel’s Office, (202) 906–6639.

SUPPLEMENTARY INFORMATION:

I

ion, (202) 898–3736.

• Thomas Nixon, Counsel, Legal

Division, (202) 898–8766.

OTS:

• Robyn Dennis, Manager, Thrift

Policy, Supervision Policy, (202) 906–

5751.

• Josephine Battle, Program Analyst,

Thrift Policy, Supervision Policy, (202)

906–6870.

• Karen Osterloh, Special Counsel,

Regulations and Legislation Division,

Chief Counsel’s Office, (202) 906–6639.

SUPPLEMENTARY INFORMATION:

I. Overview of the EGRPRA Review and

the Steps Taken So Far

The Agencies 1 are asking for your

comments and suggestions on ways in

which we can reduce regulatory

burdens consistent with our statutory

obligations. Today, we request your

input to help us identify which

regulatory requirements in the category

‘‘Consumer Protection: Account/Deposit

Relationships and Miscellaneous

Consumer Rules’ are outdated,

unnecessary, or unduly burdensome.

We list the rules in this category in a

chart at the end of this notice. Please

send us your recommendations at our

Web site, http://www.EGRPRA.gov, or to

one of the listed addresses.

Today’s request for comment is the

third notice in our multi-year review of

regulations for burden reduction

required by section 2222 of EGRPRA.2

We described the EGRPRA review’s

requirements in our first EGRPRA

notice. In summary, EGRPRA requires

us to:

• Categorize our regulations by type.

• Publish the regulations by category

to request comments on which

regulations contain requirements that

are:

• Outdated,

• Unnecessary, or

• Unduly burdensome.

• Publish a summary of those

comments.

• Eliminate unnecessary regulations

to the extent appropriate.

• Report to Congress:

• Summarizing the significant issues

raised and their relative merits

• Analyzing whether legislative change

is required to reduce burden.

The first publication cycle must be

complete by September 2006.

We have identified 13 categories of

rules to implement our EGRPRA review

a summary of those

comments.

• Eliminate unnecessary regulations

to the extent appropriate.

• Report to Congress:

• Summarizing the significant issues

raised and their relative merits

• Analyzing whether legislative change

is required to reduce burden.

The first publication cycle must be

complete by September 2006.

We have identified 13 categories of

rules to implement our EGRPRA review.

The categories are: Applications and

Reporting; Banking Operations; Capital;

Community Reinvestment Act;

Consumer Protection: Lending Related

Rules; Consumer Protection: Account/

Deposit Relationships and

Miscellaneous Consumer Rules;

Directors, Officers and Employees;

International Operations; Money

Laundering; Powers and Activities;

Rules of Procedure; Safety and

Soundness; and Securities. You may see

the categories and the rules placed

within them at our Web site http://

www.EGRPRA.gov.

We previously requested public

comment about possible burden

reduction in four categories of rules.

Our June 16, 2003, notice requested

comment on three categories:

Applications and Reporting, Powers and

Activities, and International Operations.

Our January 21, 2004, notice requested

comment on Consumer Protection:

Lending Related Rules. Today, we

request comment on Consumer

Protection: Account/Deposit

Relationships and Miscellaneous

Consumer Rules.

We plan to publish one or more

categories of rules approximately every

six months between 2003 and 2006 and

provide a 90-day comment period for

each publication. As noted earlier, we

must publish all our covered categories

of rules for comment and review them

by the end of September 2006.

In addition to soliciting written

comments, we held banker outreach

meetings in Orlando, St. Louis, Denver,

San Francisco, New York City,

Nashville and Seattle to hear directly

from the industry about ways the

Agencies could reduce regulatory

burden. More than 300 representatives

from the industry have attended the

outreach meetings

comment and review them

by the end of September 2006.

In addition to soliciting written

comments, we held banker outreach

meetings in Orlando, St. Louis, Denver,

San Francisco, New York City,

Nashville and Seattle to hear directly

from the industry about ways the

Agencies could reduce regulatory

burden. More than 300 representatives

from the industry have attended the

outreach meetings. On February 20,

2004, the Agencies also held a

conference in the Washington, DC area

for consumer groups to obtain their

input on regulatory burden reduction.

Another consumer group meeting was

held in San Francisco on June 24, 2004.

These meetings have helped focus our

regulatory burden reduction efforts. We

anticipate holding additional outreach

events this year. You may learn more

about the meetings and related

recommendations at our EGRPRA Web

site (http://www.EGRPRA.gov).

We received 19 comments in response

to the first notice and over 590 to the

second notice. The Agencies appreciate

the response to our notices and the

outreach meetings. The written

comments and remarks at the meetings

came from individuals, banks, savings

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Federal Register / Vol. 69, No. 138 / Tuesday, July 20, 2004 / Proposed Rules

associations, holding companies,

industry trade groups, and consumer

and community groups. You may view

the comments at our EGRPRA Web site

(http://www.EGRPRA.gov). We are

actively reviewing the feedback received

about specific ways to reduce regulatory

burden, as well as conducting our own

analyses.

On May 12, 2004, FDIC Vice

Chairman John M. Reich testified about

burden reduction before the

Subcommittee on Financial Institutions

and Consumer Credit of the House

Committee on Financial Services. On

June 22, 2004, Agency and industry

leaders testified about regulatory reform

before the Senate Committee on

Banking, Housing and Urban Affairs

den, as well as conducting our own

analyses.

On May 12, 2004, FDIC Vice

Chairman John M. Reich testified about

burden reduction before the

Subcommittee on Financial Institutions

and Consumer Credit of the House

Committee on Financial Services. On

June 22, 2004, Agency and industry

leaders testified about regulatory reform

before the Senate Committee on

Banking, Housing and Urban Affairs.

Agency leaders included Federal

Reserve Board Governor Donald Kohn,

FDIC Vice Chairman John M. Reich,

NCUA Chairman JoAnn Johnson, OCC

First Senior Deputy Comptroller and

Chief Counsel Julie L. Williams, and

OTS Chief Counsel John Bowman. We

will continue to post information about

our burden reduction efforts at our Web

site.

II. Request for Comment on Consumer

Protection: Account/Deposit

Relationships and Miscellaneous

Consumer Rules

Today, we are asking the public to

identify the ways in which the

Consumer Protection: Account/Deposit

Relationships and Miscellaneous

Consumer Rules may be outdated,

unnecessary, or unduly burdensome.

We chose this category for publication

relatively early in the series of requests

for comment based on earlier comments

from some industry representatives that

the requirements imposed by the

consumer protection regulations are

among the most burdensome. As shown

on the chart at the end of this notice,

there are 11 regulations in this category.

We encourage comments that address

not only individual rules or

requirements but also pertain to certain

product lines. For example, in the case

of a particular deposit product, are any

disclosure requirements under one

regulation inconsistent with or

duplicative of requirements under

another regulation? Do the rules require

that you keep unnecessary records? A

product line approach is consistent with

EGRPRA’s focus on how rules interact,

and may be especially helpful in

exposing redundant or potentially

inconsistent regulatory requirements

ular deposit product, are any

disclosure requirements under one

regulation inconsistent with or

duplicative of requirements under

another regulation? Do the rules require

that you keep unnecessary records? A

product line approach is consistent with

EGRPRA’s focus on how rules interact,

and may be especially helpful in

exposing redundant or potentially

inconsistent regulatory requirements.

We recognize that commenters using a

product line approach may want to

make recommendations about rules that

are not in our current request for

comment. They should do so since we

designed the EGRPRA categories to

stimulate creative approaches rather

than limiting them.

Specific issues to consider: While all

comments are welcome, we specifically

invite comment on the following issues:

A. Need for statutory change. (1) Do

any statutory requirements underlying

the rules impose unnecessary,

redundant, conflicting or unduly

burdensome requirements? (2) Are there

less burdensome alternatives?

B. Need and purpose of the

regulations. (1) Are the regulations

consistent with the purposes of the

statutes that they implement? (2) Have

circumstances changed so that a rule is

no longer necessary? (3) Do changes in

the financial products and services

offered to consumers suggest a need to

revise certain regulations (or statutes)?

(4) Do any of the regulations impose

compliance burdens not required by the

statutes they implement?

C. General approach/flexibility. (1)

Would a different general approach to

regulating achieve statutory goals with

less burden? (2) Do any of these rules

impose unnecessarily inflexible

requirements?

D. Effect of the regulations on

competition. Do any of the regulations

or statutes create competitive

disadvantages for insured depository

institutions compared to the rest of the

financial services industry or

competitive disadvantages for one type

of insured depository institution over

another?

E. Reporting, recordkeeping and

disclosure requirements

ecessarily inflexible

requirements?

D. Effect of the regulations on

competition. Do any of the regulations

or statutes create competitive

disadvantages for insured depository

institutions compared to the rest of the

financial services industry or

competitive disadvantages for one type

of insured depository institution over

another?

E. Reporting, recordkeeping and

disclosure requirements. (1) Which

reporting, recordkeeping, or disclosure

requirements impose the most

compliance burdens? (2) Are any of the

reporting or recordkeeping requirements

unnecessary to demonstrate compliance

with the law?

F. Consistency and redundancy. (1)

Are any of the requirements under one

regulation inconsistent with or

duplicative of requirements under

another regulation? (2) If so, are the

inconsistencies not warranted by the

purposes of the regulations?

G. Clarity. Are any of the regulations

drafted unclearly?

H. Burden on small insured

institutions. We have particular interest

in minimizing burden on small insured

institutions (those with assets of $150

million or less). How could we amend

these rules to minimize adverse

economic impact on small insured

institutions?

The Agencies appreciate the efforts of

all interested parties to help us

eliminate outdated, unnecessary, or

unduly burdensome regulatory

requirements.

BILLING CODE 4810–33–P; 6210–01–P; 6714–01–P;

6720–01–P

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ents.

BILLING CODE 4810–33–P; 6210–01–P; 6714–01–P;

6720–01–P

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Federal Register / Vol. 69, No. 138 / Tuesday, July 20, 2004 / Proposed Rules

BILLING CODE 4810–33–C; 6210–01–C; 6714–01–C;

6720–01–C

Dated: July 14, 2004.

John D. Hawke, Jr.,

Comptroller of the Currency.

By order of the Board of Governors of the

Federal Reserve System on July 6, 2004.

Robert deV. Frierson,

DeputySecretary of the Board.

Dated in Washington, DC, this 28 day of

June, 2004.

By order of the Board of Directors.

Federal Deposit Insurance Corporation.

Valerie J. Best,

Assistant Executive Secretary.

Dated: June 24, 2004.

James E. Gilleran,

Director, Office of Thrift Supervision.

[FR Doc. 04–16401 Filed 7–19–04; 8:45 am]

BILLING CODE 4810–33–P; 6210–01–P; 6714–01–P;

6720–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 312, 314, 600, and 601

[Docket No. 2004N–0267]

Applications for Approval to Market a

New Drug; Complete Response Letter;

Amendments to Unapproved

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend our regulations on new drug

applications (NDAs) and abbreviated

new drug applications (ANDAs) for

approval to market new drugs and

generic drugs. We propose to

discontinue the use of approvable letters

and not approvable letters when taking

action on marketing applications.

Instead, we intend to use complete

response letters to indicate that the

review cycle is complete and that the

application is not ready for approval

cations (NDAs) and abbreviated

new drug applications (ANDAs) for

approval to market new drugs and

generic drugs. We propose to

discontinue the use of approvable letters

and not approvable letters when taking

action on marketing applications.

Instead, we intend to use complete

response letters to indicate that the

review cycle is complete and that the

application is not ready for approval.

We also are proposing to revise the

regulations on extending the review

cycle due to the submission of an

amendment to an unapproved

application and starting a new cycle

after a resubmission following receipt of

a complete response letter. In addition,

we are proposing to add to the

regulations on biologics license

applications (BLAs) a provision on the

issuance of complete response letters to

BLA applicants. We are taking these

actions to implement the user fee

performance goals referenced in the

Prescription Drug User Fee

Amendments of 2002 that address

procedures and establish target

timeframes for reviewing human drug

applications.

DATES: Submit written or electronic

comments by October 18, 2004. See

section VIII of this document for the

proposed effective date of a final rule

based on this document.

ADDRESSES: You may submit comments,

identified by [Docket No. 2004N–0267],

by any of the following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the

instructions for submitting comments.

• Agency Web Site: http://

www.fda.gov/dockets/ecomments.

Follow the instructions for submitting

comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov.

Include [Docket No. 2004N–0267] in the

subject line of your e-mail message.

• Fax: 301–827–6870.

• Mail/Hand delivery/Courier [For

paper, disk, or CD–ROM submissions]:

Division of Dockets Management (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

Instructions: All submissions received

must include the agency name and

[Docket No. 2004N–0267] for this

rulemaking

t No. 2004N–0267] in the

subject line of your e-mail message.

• Fax: 301–827–6870.

• Mail/Hand delivery/Courier [For

paper, disk, or CD–ROM submissions]:

Division of Dockets Management (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

Instructions: All submissions received

must include the agency name and

[Docket No. 2004N–0267] for this

rulemaking. All comments received will

be posted without change to http://

www.fda.gov/dockets/ecomments,

including any personal information

provided. For detailed instructions on

submitting comments and additional

information on the rulemaking process,

see the ‘‘Request for Comments’’

heading in the SUPPLEMENTARY

INFORMATION section of this document.

Docket: For access to the docket to

read background documents or

comments received, go to http://

www.fda.gov/dockets/ecomments and/

or the Division of Dockets Management,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

The Office of Management and Budget

(OMB) is still experiencing significant

delays in the regular mail, including

first class and express mail, and

messenger deliveries are not being

accepted. To ensure that comments on

the information collection are received,

OMB recommends that written

comments be faxed to the Office of

Information and Regulatory Affairs,

OMB, Attn: Fumie Yokota, Desk Officer

for FDA, FAX: 202–395–6974.

FOR FURTHER INFORMATION CONTACT:

Brian L. Pendleton, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

5523.

SUPPLEMENTARY INFORMATION:

I. Background

A. User Fee Performance Goals and

Complete Response Letters

In conjunction with the Prescription

Drug User Fee Act of 1992 (PDUFA)

(Public Law 102–571), we committed to

meet certain goals for reviewing and

acting on human drug applications, as

defined in section 735(1) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 379g(1))

–

5523.

SUPPLEMENTARY INFORMATION:

I. Background

A. User Fee Performance Goals and

Complete Response Letters

In conjunction with the Prescription

Drug User Fee Act of 1992 (PDUFA)

(Public Law 102–571), we committed to

meet certain goals for reviewing and

acting on human drug applications, as

defined in section 735(1) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 379g(1)). For example, we

promised that by September 30, 1997,

we would review and act on at least 90

percent of standard NDAs within 12

months after the submission date (H.

Rep. No. 895, 102d Cong., 2d. sess. 32

(1992) (letter from David A. Kessler,

M.D., Commissioner of Food and Drugs,

to Representatives John Dingell and

Norman Lent, House Committee on

Energy and Commerce (September 14,

1992))).

FDA’s drug application review

performance goals were revised with the

enactment of the Food and Drug

Administration Modernization Act of

1997 (Public Law 105–115) (the user fee

provisions of this act are known as

‘‘PDUFA II’’). The goals were further

revised in conjunction with the

enactment of the Prescription Drug User

Fee Amendments of 2002 (PDUFA III),

set forth in title V, subtitle A, of the

Public Health Security and Bioterrorism

Preparedness and Response Act of 2002

(Public Law 107–188). Section 502 of

PDUFA III states that user fees will be

dedicated to expediting the drug

development process and the process

for the review of human drug

applications in accordance with the new

performance goals, which are set forth

in an enclosure to letters from Tommy

Thompson, Secretary of Health and

Human Services, to the Chairman of the

House Committee on Energy and

Commerce and the Ranking Member of

the Senate Committee on Health,

Education, Labor and Pensions (June 4,

2002) (Goals Letter)

d the process

for the review of human drug

applications in accordance with the new

performance goals, which are set forth

in an enclosure to letters from Tommy

Thompson, Secretary of Health and

Human Services, to the Chairman of the

House Committee on Energy and

Commerce and the Ranking Member of

the Senate Committee on Health,

Education, Labor and Pensions (June 4,

2002) (Goals Letter).

Under the user fee performance goals,

the term ‘‘review and act on’’ is defined

as the issuance of a complete action

letter after the complete review of a

complete application that we have

accepted for filing (Goals Letter at 15).

An action letter, if not an approval,

states the specific deficiencies of the

application, and where appropriate, the

actions necessary to place the

application in condition for approval

(id.).

As part of the user fee performance

goals (first in PDUFA II and again in

PDUFA III), FDA’s Center for Drug

Evaluation and Research (CDER) and

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