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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:

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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

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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

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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]
BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2009–0001]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Notice; 60-day notice and
request for comments; revision of a
currently approved information
collection; OMB No. 1660–0099; FEMA
Form 646–0, Citizen Corps Individual
Registration.
SUMMARY: The Federal Emergency
Management Agency, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
agencies to take this opportunity to
comment on a proposed revision of a
currently approved information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
Notice seeks comments concerning the
online registration process for Citizen
Corps Individual Registration.
DATES: Comments must be submitted on
or before October 13, 2009.
ADDRESSES: To avoid duplicate
submissions to the docket, please use
only one of the following means to
submit comments:

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Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
(1) Online. Submit comments at
www.regulations.gov under docket ID
FEMA–2009–0001. Follow the
instructions for submitting comments.
(2) Mail. Submit written comments to
Office of Chief Counsel, Regulation and
Policy Team, DHS/FEMA, 500 C Street,
SW., Room 835, Wash, DC 20472–3100.
(3) Facsimile. Submit comments to
(703) 483–2999.
(4) E-mail. Submit comments to
FEMA–[email protected]. Include
docket ID FEMA–2009–0001 in the
subject line.
All submissions received must
include the agency name and docket ID.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at http://www.regulations.gov,
and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to read the
Privacy Act notice that is available on
the Privacy and Use Notice link on the
Administration Navigation Bar of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:
Contact Kerry Hoerth, Community
Preparedness Division Program
Specialist, FEMA, 202–786–9775 for
additional information. You may
contact the Records Management
Branch for copies of the proposed
collection of information at facsimile
number (202) 646–3347 or e-mail
address: FEMA–[email protected].

Citizen
Corps was launched as a Presidential
Initiative, Executive Order 13254, in
2002 with a mission to harness the
power of every individual through
education, training, and volunteer
service to make communities safer,
stronger, and better prepared for the
threats of terrorism, crime, public health
issues, and disasters of all kinds. In
order to fulfill its mission, the Federal
Emergency Management Agency
(FEMA) Community Preparedness
Division (CPD) requires individuals to
submit profiles electronically through
its information collection online process
and forms.

SUPPLEMENTARY INFORMATION:

Collection of Information
Title: Citizen Corps Individual
Registration.
Type of Information Collection:
Revision of a currently approved
information collection.
OMB Number: OMB No. 1660–0099.
Form Titles and Numbers: FEMA
Form 646–0, Citizen Corps Individual
Registration.
Abstract: FEMA’s Community
Preparedness Division (CPD) would like
to revise a currently approved collection
for its individual registration to allow
members of the public to provide
contact information to receive national
programmatic updates and
announcements such as upcoming
preparedness demonstrations and
training opportunities and the
opportunity to get involved in local
organizations and events.
Affected Public: Individuals or
households.
Estimated Total Annual Burden
Hours: 1,600 burden hours.

ANNUAL HOUR BURDEN
TABLE A.12—ESTIMATED ANNUALIZED BURDEN HOURS AND COSTS
Form name/
form No.

Type of respondent

Number of respondents

Number of responses per
respondent

Avg. burden
per response
(in hours)

Total annual
burden (in
hours)

Avg. hourly
wage rate*

Total annual
respondent
cost

Individuals or households .........................

FEMA Form

20,000

1

5 minutes
(.08 hours)

1,600

27.38

43,808.00

Total ......................

........................

20,000

........................

........................

1,600

........................

43,808.00

* Note: The ‘‘Avg. Hourly Wage Rate’’ for each respondent includes a 1.4 multiplier to reflect a fully-loaded wage rate.

e.g., permitting electronic submission of
responses.

Estimated Cost: None.

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Comments
Comments may be submitted as
indicated in the ADDRESSES caption
above. Comments are solicited to (a)
evaluate whether the proposed data
collection is necessary for the proper
performance of the agency, including
whether the information shall have
practical utility; (b) evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) enhance the quality, utility, and
clarity of the information to be
collected; and (d) minimize the burden
of the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,

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Larry Gray,
Director, Records Management Division,
Office of Management, Federal Emergency
Management Agency, Department of
Homeland Security.
[FR Doc. E9–19154 Filed 8–10–09; 8:45 am]
BILLING CODE 9111–05–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2009–0001]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Federal Emergency
Management Agency, DHS.

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ACTION: Notice; 60-day notice and
request for comments; revision of a
currently approved information
collection; OMB No. 1660–0098; FEMA
Form 646, Citizen Corps Council
Registration.
SUMMARY: The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public and other
Federal agencies to take this
opportunity to comment on a proposed
revision of a currently approved
information collection. In accordance
with the Paperwork Reduction Act of
1995, this Notice seeks comments
concerning the online database of
Citizen Corps Councils and Community
Emergency Response Team (CERT) so
that they can submit profiles via the
national Web site. Approved registration
of a Council or CERT program allows
them to be recognized as official entities

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