# FDIC FIL-86-2004: Reducing Regulatory Burden

> Federal · Agency guidance · Superseded

URL: https://www.frixlaw.com/law-library/statutes/FDIC_FIL04086

## Section

- **Citation:** FDIC FIL-86-2004
- **Heading:** Reducing Regulatory Burden
- **Jurisdiction:** Federal
- **Kind:** Agency guidance
- **Status:** Superseded
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** FDIC Financial Institution Letters / Reducing Regulatory Burden

## Text

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outdated, unnecessary, or unduly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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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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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FDIC_FIL04086. Check the current official text before relying on it. Not legal advice.