Review of Post-Inspection Responses, 40211-40212 [E9-19107]
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Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
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Dated: August 4, 2009.
Jennifer Spaeth,
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[FR Doc. E9–19092 Filed 8–10–09; 8:45 am]
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Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19089 Filed 8–10–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
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National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Meeting
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hereby given of the following meeting.
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Natcher Building, Room 3AN18, 45 Center
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Arthritis and Musculoskeletal
and Skin Diseases Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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Name of Committee: National Arthritis and
Musculoskeletal and Skin Diseases Advisory
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Date: September 16, 2009.
Open: 8:30 a.m. to 12 p.m.
Agenda: To discuss administrative details
relating to the Council’s business and special
Reports.
Place: National Institutes of Health,
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Closed: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
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Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6, Bethesda, MD 20892.
Contact Person: Susana Serrate-Sztein, MD,
Director, Division of Skin and Rheumatic
Diseases, NIAMS/NIH, 6701 Democracy
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(301) 594–5032. szteins@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research;
93.701, ARRA Related Biomedical Research
and Research Support Awards., National
Institutes of Health, HHS)
Dated: August 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19219 Filed 8–10–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0335]
Review of Post-Inspection Responses
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
program to support public health
protection by facilitating the timely
issuance of warning letters. The
program establishes a timeframe for the
submission and agency review of postinspection responses to inspectional
E:\FR\FM\11AUN1.SGM
11AUN1
40212
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
observations that are communicated to a
firm through issuance of a form FDA
483, list of inspectional observations.
DATES: The program will begin on
September 15, 2009.
FOR FURTHER INFORMATION CONTACT:
Karen Stutsman, Division of
Compliance Policy (HFC–230), Office of
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 240–632–6860.
SUPPLEMENTARY INFORMATION:
sroberts on DSKD5P82C1PROD with NOTICES
I. Background
FDA issues a form FDA 483,
Inspectional Observations, upon
completion of an inspection, to notify
an inspected establishment’s top
management of objectionable conditions
relating to products and/or processes, or
other violations of the Federal Food,
Drug, and Cosmetic Act and related acts,
that were observed during the
inspection.
The FDA 483 form includes this
preprinted instruction: ‘‘This document
lists observations made by the FDA
representative(s) during the inspection
of your facility. They are inspectional
observations; and do not represent a
final agency determination regarding
your compliance. If you have an
objection regarding an observation, or
have implemented, or plan to
implement corrective action in response
to an observation, you may discuss the
objection or action with the FDA
representative(s) during the inspection
or submit this information to FDA at the
address [on the form].’’
When FDA determines, based on the
inspection, that the establishment is in
violation of the Federal Food, Drug, and
Cosmetic Act or another statute that we
enforce, we may issue a warning letter.
Warning letters are issued only for
significant violations that may lead to
enforcement action if they are not
promptly and adequately corrected. The
decision to issue a warning letter is
made by senior officials within FDA,
often including the product center, after
a thorough review of all of the relevant
facts.
It is not uncommon for an inspected
establishment to respond in writing to
observations made on an FDA 483 to
describe completed or ongoing
corrective actions or to promise future
corrections. In fact, some inspected
establishments submit multiple
responses to FDA, sometimes over many
months. Delayed and multiple
responses to an FDA 483 have resulted
in delays in the issuance of warning
letters while these responses are
reviewed and addressed. FDA’s timely
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
issuance of a warning letter should help
to achieve prompt voluntary compliance
and is therefore in the public interest.
While FDA considers corrective
actions, and other factors, in
determining whether to issue a warning
letter, ongoing or promised corrective
actions generally do not preclude the
issuance of a warning letter. A warning
letter is an important means of notifying
regulated industry of violations and
achieving prompt voluntary correction.
Warning letters serve to ensure that the
seriousness and scope of the violations
are understood by top management of
the inspected establishment, and that
the appropriate resources are allocated
to fully correct the violations and to
prevent their recurrence. FDA is
initiating a program to establish a
timeframe for the submission of such
post-inspection responses to FDA 483
inspectional observations for FDA’s
consideration in deciding whether to
issue a warning letter. Under the
program (described in more detail later
in this document), the agency will not
ordinarily delay the issuance of a
warning letter in order to review a
response to an FDA 483 that is received
more than 15 business days after the
FDA 483 was issued.
The purpose of this program is to
optimize resource utilization, facilitate
the timely issuance of warning letters,
and promote prompt correction of
violations. FDA will use the information
from the program to determine whether
to make the program permanent. FDA
will conduct an assessment of the
program after approximately 18 months.
II. Program Description
Under the program, before issuing a
warning letter, FDA will generally allow
firms 15 business days to provide a
response to FDA 483 observations. If we
receive a response to FDA 483
observations within 15 business days
after the FDA 483 was issued, we plan
to conduct a detailed review of the
response before determining whether to
issue a warning letter. If we issue a
warning letter after reviewing a firm’s
timely response, the warning letter will
recognize receipt of the response and
reply as to the apparent adequacy of the
firm’s corrective actions set forth in the
response. Additional correspondence
from FDA may be issued with regard to
the response, if needed.
If we receive a response to FDA 483
observations more than 15 business
days after the FDA 483 was issued, we
do not plan to routinely include a
response on the apparent adequacy of
the firm’s corrective actions in the
warning letter. Rather, we plan to
evaluate the response along with any
PO 00000
Frm 00058
Fmt 4703
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other written material provided as the
direct response to the warning letter (a
firm’s response to a warning letter may
reference any of the firm’s earlier
responses).
Note that FDA, at its discretion, may
issue Warning Letters at any time,
independent of receiving a response;
and that firms are expected to
implement needed corrections to
conform to the requirements of the
Federal Food, Drug, and Cosmetic Act
and associated regulations regardless of
whether they respond in writing to FDA
or whether such a response is reviewed
by FDA.
After the 18-month time period, FDA
will evaluate this program and decide
whether to continue it with or without
adjustments.
Dated: August 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19107 Filed 8–10–09; 8:45 am]
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[Docket ID FEMA–2009–0001]
Agency Information Collection
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AGENCY: Federal Emergency
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ACTION: Notice; 60-day notice and
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E:\FR\FM\11AUN1.SGM
11AUN1
Agencies
[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Pages 40211-40212]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19107]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0335]
Review of Post-Inspection Responses
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a program
to support public health protection by facilitating the timely issuance
of warning letters. The program establishes a timeframe for the
submission and agency review of post-inspection responses to
inspectional
[[Page 40212]]
observations that are communicated to a firm through issuance of a form
FDA 483, list of inspectional observations.
DATES: The program will begin on September 15, 2009.
FOR FURTHER INFORMATION CONTACT: Karen Stutsman, Division of
Compliance Policy (HFC-230), Office of Enforcement, Office of
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240-632-6860.
SUPPLEMENTARY INFORMATION:
I. Background
FDA issues a form FDA 483, Inspectional Observations, upon
completion of an inspection, to notify an inspected establishment's top
management of objectionable conditions relating to products and/or
processes, or other violations of the Federal Food, Drug, and Cosmetic
Act and related acts, that were observed during the inspection.
The FDA 483 form includes this preprinted instruction: ``This
document lists observations made by the FDA representative(s) during
the inspection of your facility. They are inspectional observations;
and do not represent a final agency determination regarding your
compliance. If you have an objection regarding an observation, or have
implemented, or plan to implement corrective action in response to an
observation, you may discuss the objection or action with the FDA
representative(s) during the inspection or submit this information to
FDA at the address [on the form].''
When FDA determines, based on the inspection, that the
establishment is in violation of the Federal Food, Drug, and Cosmetic
Act or another statute that we enforce, we may issue a warning letter.
Warning letters are issued only for significant violations that may
lead to enforcement action if they are not promptly and adequately
corrected. The decision to issue a warning letter is made by senior
officials within FDA, often including the product center, after a
thorough review of all of the relevant facts.
It is not uncommon for an inspected establishment to respond in
writing to observations made on an FDA 483 to describe completed or
ongoing corrective actions or to promise future corrections. In fact,
some inspected establishments submit multiple responses to FDA,
sometimes over many months. Delayed and multiple responses to an FDA
483 have resulted in delays in the issuance of warning letters while
these responses are reviewed and addressed. FDA's timely issuance of a
warning letter should help to achieve prompt voluntary compliance and
is therefore in the public interest.
While FDA considers corrective actions, and other factors, in
determining whether to issue a warning letter, ongoing or promised
corrective actions generally do not preclude the issuance of a warning
letter. A warning letter is an important means of notifying regulated
industry of violations and achieving prompt voluntary correction.
Warning letters serve to ensure that the seriousness and scope of the
violations are understood by top management of the inspected
establishment, and that the appropriate resources are allocated to
fully correct the violations and to prevent their recurrence. FDA is
initiating a program to establish a timeframe for the submission of
such post-inspection responses to FDA 483 inspectional observations for
FDA's consideration in deciding whether to issue a warning letter.
Under the program (described in more detail later in this document),
the agency will not ordinarily delay the issuance of a warning letter
in order to review a response to an FDA 483 that is received more than
15 business days after the FDA 483 was issued.
The purpose of this program is to optimize resource utilization,
facilitate the timely issuance of warning letters, and promote prompt
correction of violations. FDA will use the information from the program
to determine whether to make the program permanent. FDA will conduct an
assessment of the program after approximately 18 months.
II. Program Description
Under the program, before issuing a warning letter, FDA will
generally allow firms 15 business days to provide a response to FDA 483
observations. If we receive a response to FDA 483 observations within
15 business days after the FDA 483 was issued, we plan to conduct a
detailed review of the response before determining whether to issue a
warning letter. If we issue a warning letter after reviewing a firm's
timely response, the warning letter will recognize receipt of the
response and reply as to the apparent adequacy of the firm's corrective
actions set forth in the response. Additional correspondence from FDA
may be issued with regard to the response, if needed.
If we receive a response to FDA 483 observations more than 15
business days after the FDA 483 was issued, we do not plan to routinely
include a response on the apparent adequacy of the firm's corrective
actions in the warning letter. Rather, we plan to evaluate the response
along with any other written material provided as the direct response
to the warning letter (a firm's response to a warning letter may
reference any of the firm's earlier responses).
Note that FDA, at its discretion, may issue Warning Letters at any
time, independent of receiving a response; and that firms are expected
to implement needed corrections to conform to the requirements of the
Federal Food, Drug, and Cosmetic Act and associated regulations
regardless of whether they respond in writing to FDA or whether such a
response is reviewed by FDA.
After the 18-month time period, FDA will evaluate this program and
decide whether to continue it with or without adjustments.
Dated: August 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19107 Filed 8-10-09; 8:45 am]
BILLING CODE 4160-01-S