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66336 Federal Register / Vol. 71, No.

219 / Tuesday, November 14, 2006 / Notices

ACTION: Notice. This includes a description of guidance practices regulation (21 CFR
practicable methods of analysis (assay 10.115). This draft guidance, when
SUMMARY: The Food and Drug methods) that have adequate sensitivity finalized, will represent the agency’s
Administration (FDA) is announcing the to determine the amount of the new current thinking on the topic. It does not
availability of draft guidance for animal drug in the final dosage form (21 create or confer any rights for or on any
industry (#136) entitled ‘‘Protocols for CFR 514.1(b)(5)(vii)(a)). In the case of a person and does not operate to bind
the Conduct of Method Transfer Studies Type A medicated article, the Type C FDA or the public. An alternate method
for Type C Medicated Feed Assay medicated feed is a final dosage form may be used as long as it satisfies the
Methods.’’ This draft guidance provides used to treat the animal. Thus as part of requirements of applicable statutes and
our recommendations for protocols for the NADA review process, FDA looks at regulations.
conducting the transfer study of a assay methods for determining the
single-laboratory validated Type C IV. Comments
amount of a new animal drug in Type
medicated feed assay method to C medicated feed. This draft guidance is being
laboratories that have no experience This draft guidance provides our (the distributed for comment purposes only
with the test method. Office of New Animal Drug Evaluation and is not intended for implementation
DATES: Submit written or electronic or ONADE) recommendations for at this time. Interested persons may
comments on this draft guidance by protocols for conducting the transfer submit to the Division of Dockets
January 29, 2007, to ensure their study of a single-laboratory validated Management (see ADDRESSES) written or
adequate consideration in preparation of Type C medicated feed assay method to electronic comments regarding this draft
the final document. General comments laboratories that have no experience guidance document. Submit a single
on agency guidance documents are with the test method. Many testing copy of electronic comments or two
welcome at any time. laboratories, including state feed paper copies of any mailed comments,
ADDRESSES: Submit written requests for laboratories and contract laboratories, except that individuals may submit one
single copies of the draft guidance to the use Type C medicated feed assay paper copy. Comments are to be
Communications Staff (HFV–12), Center methods to determine whether the drug identified with the docket number
for Veterinary Medicine, Food and Drug in a medicated feed is within the assay found in brackets in the heading of this
Administration, 7519 Standish Pl., limits. The term ‘‘assay limits’’ refers to document. Received comments may be
Rockville, MD 20855. Send one self- the amount of the drug detected when seen in the Division of Dockets
addressed adhesive label to assist that a Type B/C feed is assayed. The limit is Management between 9 a.m. and 4 p.m.,
office in processing your requests. a range that is codified at 21 CFR Monday through Friday.
Submit written comments to the 558.4(d). When feed assay values fall
within this range, it indicates that the V. Electronic Access
Division of Dockets Management (HFA–
feed has been prepared with the correct Electronic comments may be
305), Food and Drug Administration,
amount of Type A medicated article. submitted on the Internet at http://
5630 Fishers Lane, rm. 1061, Rockville,
Because many different laboratories use www.fda.gov/dockets/ecomments.
MD 20852. Comments should be
medicated feed assays, it is important Copies of the draft guidance document
identified with the full title of the draft
that the assay methods are reproducible. entitled ‘‘Protocols for the Conduct of
guidance and the docket number found
Sponsors should conduct method Method Transfer Studies for Type C
in brackets in the heading of this
transfer studies to evaluate Medicated Feed Assay Methods’’ may
document. Submit electronic comments
reproducibility. A method transfer study be obtained from the CVM Home Page
to http://www.fda.gov/dockets/
is part of the evaluation process for a (http://www.fda.gov/cvm) and from the
ecomments. See the SUPPLEMENTARY
Type C medicated feed assay method Division of Dockets Management Web
INFORMATION section for electronic
and demonstrates the transferability of site (http://www.fda.gov/ohrms/dockets/
access to the draft guidance document.
the feed assay method among different default.htm).
FOR FURTHER INFORMATION CONTACT:
laboratories by comparing the results Dated: November 7, 2006.
Rebecca L. Owen, Center for Veterinary each laboratory obtains when using the
Medicine (HFV–141), Food and Drug Jeffrey Shuren,
method to analyze a specific set of feed Assistant Commissioner for Policy.
Administration, 7500 Standish Pl., samples. Sponsors may expand the
Rockville, MD 20855, 240–276–9842, e- [FR Doc. E6–19204 Filed 11–13–06; 8:45 am]
method transfer study to include other
mail: rebecca.owen@fda.hhs.gov. medicated feed products, such as Top
BILLING CODE 4160–01–S

SUPPLEMENTARY INFORMATION: Dress Type C, Free-Choice Type C, and


I. Background Type B medicated feeds. DEPARTMENT OF HEALTH AND
Section 512(b) of the Federal Food, II. Paperwork Reduction Act of 1995 HUMAN SERVICES
Drug, and Cosmetic Act (21 U.S.C. 360b) This draft guidance refers to Food and Drug Administration
establishes the requirements for a new previously approved collections of
animal drug approval. FDA regulations information found in FDA regulations. [Docket No. 2006D–0419]
specify the information you (the These collections of information are
sponsor) must submit as part of your Draft Voluntary National Retail Food
subject to review by the Office of
new animal drug application (NADA) Regulatory Program Standards;
Management and Budget (OMB) under
and the proper format for the NADA Availability
the Paperwork Reduction Act of 1995
submission (§ 514.1 (21 CFR 514.1)). As (44 U.S.C. 3501–3520). The collections AGENCY: Food and Drug Administration,
part of your NADA submission, you of information in § 514.1 have been HHS.
must describe analytical procedures
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approved under OMB control nos. ACTION: Notice.


capable of determining the active 0910–0032 and 0910–0154.
component(s) of the new animal drug SUMMARY: The Food and Drug
within a reasonable degree of accuracy III. Significance of Guidance Administration (FDA) is announcing the
and of assuring the identity of such This draft level 1 guidance is being availability of a draft document entitled
components (21 CFR 514.1(b)(5)(vii)). issued consistent with FDA’s good ‘‘Voluntary National Retail Food

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Federal Register / Vol. 71, No. 219 / Tuesday, November 14, 2006 / Notices 66337

Regulatory Program Standards’’ (the The Centers for Disease Control and information will have practical utility;
Program Standards). The Program Prevention has identified the major (2) the accuracy of FDA’s estimate of the
Standards are intended to help state, contributing factors associated with burden of the proposed collection of
local, and tribal regulators design and foodborne illness outbreaks. Five of information, including the validity of
manage a retail food regulatory program these contributing factors directly relate the methodology and assumptions used;
that is focused on the reduction of to retail and foodservice establishments (3) ways to enhance the quality, utility,
foodborne illness risk factors. and are called ‘‘foodborne illness risk and clarity of the information to be
DATES: Submit written or electronic factors’’ by FDA. In an effort to assist collected; and (4) ways to minimize the
comments concerning the draft Program state, local, and tribal regulators and the burden of the collection of information
Standards document and its retail and food service entities they on respondents, including through the
recommendations for collection of regulate, FDA developed draft Program use of automated collection techniques,
information by January 16, 2007. Standards. when appropriate, and other forms of
ADDRESSES: Submit written requests for The Program Standards were information technology.
single copies of the draft Program developed to address the need for Title: Voluntary National Retail Food
Standards document to Glenda R. national uniformity among retail food Regulatory Program Standards
regulatory programs, to promote In the Federal Register of May 9, 2001
Lewis, Center for Food Safety and
uniform application of the FDA Food (66 FR 23715), a 60-day notice was
Applied Nutrition (HFS–626), Food and
Code, and to reduce the occurrence of published soliciting comments on
Drug Administration, 5100 Paint Branch
foodborne illness risk factors. The FDA’s collection of information from
Pkwy., College Park, MD 20740, 301–
Program Standards were developed with local, state and tribal authorities
436–2150. Send one self-addressed
extensive input from state, tribal, and concerning their use of or planned use
adhesive label to assist that office in
local regulatory authorities. They of FDA’s Program Standards. No
processing your request. Submit written
capture the best management practices comments were received in response to
comments concerning the draft Program
currently in use by those authorities and that notice. The agency has decided to
Standards document and its
are intended to help those authorities reissue this 60-day notice for further
recommendations for collection of comment because the Program
design and manage a retail food
information to the Division of Dockets Standards have been revised since the
regulatory program that is focused on
Management (HFA–305), Food and Drug previous notice. The January 2005
the reduction of foodborne illness risk
Administration, 5630 Fishers Lane, rm. revision of the Program Standards is
factors.
1061, Rockville, MD 20852. Submit The incorporation of a risk-based available in draft for comment on FDA’s
electronic comments on the draft methodology into regulatory inspection Web site at http://www.cfsan.fda.gov/
Program Standards document and its programs is an important element in ~dms/ret3toc.html.
recommendations for collection of reaching the goals established by the The Program Standards define nine
information to http://www.fda.gov/ President’s Council on Food Safety in essential elements of an effective
dockets/ecomments. All comments the document entitled ‘‘Food Safety regulatory program for retail food
should be identified with the docket Strategic Plan’’ released in January 2001 establishments, establish basic quality
number found in brackets in the (available at http://www.foodsafety.gov/ control criteria for each element, and
heading of this document. See the ~fsg/cstrpl–4.html) as well as FDA’s provide a means of recognition for those
SUPPLEMENTARY INFORMATION food safety program goals. state, local, and tribal regulatory
section for electronic access to the draft programs that meet the Program
manuals and received comments. II. Paperwork Reduction Act of 1995 Standards. The program elements
FOR FURTHER INFORMATION CONTACT: Under the Paperwork Reduction Act addressed by the Program Standards are
Glenda R. Lewis, Center for Food Safety of 1995 (the PRA) (44 U.S.C. 3501– as follows: (1) Regulatory foundation,
and Applied Nutrition (HFS–626), Food 3520), Federal agencies must obtain (2) trained regulatory staff, (3)
and Drug Administration, 5100 Paint approval from the Office of Management inspection program based on HACCP
Branch Pkwy., College Park, MD 20740– and Budget (OMB) for each collection of principles, (4) uniform inspection
3835, 301–436–2150. information they conduct or sponsor. program, (5) foodborne illness and food
SUPPLEMENTARY INFORMATION: ‘‘Collection of information’’ is defined security preparedness and response, (6)
in 44 U.S.C. 3502(3) and 5 CFR compliance and enforcement, (7)
I. Background 1320.3(c) and includes agency requests industry and community relations, (8)
While the responsibility for regulating or requirements that members of the program support and resources, and (9)
retail and foodservice establishments public submit reports, keep records, or program assessment. Each standard
lies primarily with state, local, and provide information to a third party. includes a list of records needed to
tribal jurisdictions, FDA provides Section 3506(c)(2)(A) of the PRA (44 document compliance with the standard
assistance to these jurisdictions through U.S.C. 3506(c)(2)(A)) requires Federal (referred to in the Program Standards
multiple means including, but not agencies to provide a 60-day notice in document as ‘‘quality records’’) and has
limited to, training and technical the Federal Register concerning each one or more corresponding appendices
assistance. Authority for providing such proposed collection of information that contain forms and worksheets to
assistance is derived from section 311 of before submitting the collection to OMB facilitate the collection of information
the Public Health Service Act (42 U.S.C. for approval. To comply with this needed to assess a retail program under
243). In addition, FDA’s mission under requirement, FDA is publishing notice that standard. The respondents are
section 903(b)(2)(A) of the Federal Food, of the proposed collection of State, local and tribal government
Drug, and Cosmetic Act (the act) (21 information set forth in this document. agencies. Regulatory agencies may use
U.S.C. 393(b)(2)(A)) includes ensuring With respect to the following existing, available records or may
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that foods are safe, wholesome, and collection of information, FDA invites choose to develop and use alternate
sanitary, and section 903(b)(4) of the act comments on: (1) Whether the proposed forms and worksheets that capture the
directs FDA to cooperate with food collection of information is necessary same information.
retailers, among others, in carrying out for the proper performance of FDA’s In the course of their normal
this part of its mission. functions, including whether the activities, state, local, and tribal

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66338 Federal Register / Vol. 71, No. 219 / Tuesday, November 14, 2006 / Notices

regulatory agencies already collect and agencies, and which can serve as quality Recordkeeping
keep on file many of the records needed records under the Program Standards. FDA’s recordkeeping burden estimate
as quality records to document State, local, and tribal regulatory includes time required for a state, local,
compliance with the end of each agencies that enroll in the Program or tribal agency to review the
Program Standard by jurisdictions that Standards and seek listing in the FDA instructions in the Program Standards,
enroll. Although the detail and format National Registry are required to report compile information from existing
in which this information is collected to FDA on the completion of the sources, and create any records
and recorded may vary by jurisdiction, following three management tasks recommended in the Program Standards
records that are kept as a usual and outlined in the Program Standards: (1) that are not already kept in the normal
customary part of normal agency Conducting a program self assessment; course of the agency’s usual and
activities include inspection records, (2) conducting a baseline survey of the customary activities. Worksheets
written quality assurance procedures regulated industry; and (3) obtaining an (Appendices) are provided to assist in
and records of quality assurance checks, independent outside audit (verification this compilation. In estimating the time
staff training certificates and other audit). All three tasks must be needed for the program self-assessment
training records, a log or database of completed within a 3-year time span. (Program Standards 1–8, shown in chart
food-related illness or injury The results are reported to FDA on Form 1 of this document), FDA considered
complaints, records of investigations FDA 3519, ‘‘FDA National Registry responses from four state and three local
resulting from such complaints, an Report,’’ and Form FDA 3520, jurisdictions that participated in an FDA
inventory of inspection equipment, ‘‘Permission to Publish in National Program Standards Pilot study. Chart 2
records of outside audits, and records of Registry.’’ These forms are located in of this document shows the estimated
outreach efforts (e.g., meeting agendas Appendix I of the Program Standards. If recordkeeping burden for the
and minutes, documentation of food a regulatory agency follows all the completion of the baseline data
safety education activities). No new recordkeeping recommendations in the collection and chart 3 of this document
recordkeeping burden is associated with individual standards and their shows the estimated recordkeeping
these existing records, which are appendices, it will have all the burden for the verification audit. The
already a part of usual and customary information needed to complete the overall program improvement cycle is a
program recordkeeping activities by forms. The time required to complete 3-year period for completion of all three
state, local, and tribal regulatory the forms is minimal. management tasks.

CHART 1.—YEAR ONE—SELF ASSESSMENT


Hours per Recordkeeper
Standard Recordkeeping Activity (Year One)

No. 1 Regulatory Founda- Self Assessment: (Appendix A1) Completion of worksheet recording results of eval- 16
tion uations and comparison on worksheets

No. 2 Trained Regulatory Self Assessment: (Appendix B1) Completion of summary worksheet of each em- 19
Staff ployee training records2

No. 3 HACCP Principles Self Assessment: (Appendix C1) Completion of worksheet documentation 4

No. 4 Uniform Inspection Self Assessment: (Appendix D1) Completion of worksheet documentation of jurisdic- 19
Program tion’s quality assurance procedures2

No. 5 Foodborne Illness Self Assessment: (Appendix E1) Completion of worksheet documentation 5
and Food Security Pre-
paredness and Response

No. 6 Compliance Enforce- Self Assessment: (Appendix F1) Selection and review of 20 to 70 establishment files 19
ment @ 25 minutes per file. Estimate is based on a mean number of 45. Completion of
worksheet

No. 7 Industry and Commu- Self Assessment: (Appendix G1) Completion of worksheet 2
nity Relations

No. 8 Program Support and Self Assessment: (Appendix H1) Selection and review of establishment files 8
Resources

Subtotal 92
1Or comparable documentation.
2Estimates will vary depending on the number of regulated food establishments and the number of inspectors employed by the jurisdiction.
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Federal Register / Vol. 71, No. 219 / Tuesday, November 14, 2006 / Notices 66339

CHART 2.—YEAR TWO—BASELINE DATA COLLECTION


Hours Per Recordkeeper
Standard Recordkeeping Activity (Year Two)

No. 9 Program Assessment Baseline Data Collection (Appendices I and J). Selection and inspection of randomly 333
selected statistical sample of 9 to 87 establishments from each of 9 facility types1
1Calculation based on mean sample size of 39 and average FDA inspection time for each establishment type. Estimates will vary depending
on the number of regulated food establishments within a jurisdiction and the number of inspectors employed by the jurisdiction.

CHART 3.—YEAR THREE—VERIFICATION AUDIT


Hours per Recordkeeper
Standard Recordkeeping Activity (Year Three)

9 Verification Audit (Appendices I and J)1 46


1We estimate that no more than 50 percent of time spent to complete self assessment of all nine Standards is spent completing verification
audit worksheets. Time will be considerably less if less than nine standards require verification audits.

FDA estimated the annual hours per participation of 500 regulatory percent of eligible agencies, or 450
recordkeeper (i.e., per enrolled jurisdictions in the Program Standards. programs, in the Program Standards by
jurisdiction) in table 1 of this document There are approximately 3,000 the year 2010. For purposes of this
by adding the recordkeeping estimates jurisdictions in the United States and its burden estimate, it is reasonable to take
for the management tasks of self territories that have retail food into account the possibility that this
assessment, baseline data collection, regulatory programs. Enrollment in the goal could be exceeded by
and verification audit (charts 1, 2, and Program Standards is voluntary, and approximately 10 percent, for a total of
3 of this document) that enrolled therefore FDA does not expect all approximately 500 participating
jurisdictions must perform during a 3- jurisdictions to participate in the near agencies.
year cycle, then dividing the total by future. In its 2002 operational plan, the
three to obtain an annual average. Thus, FDA estimates the burden for
FDA National Retail Food Team this collection of information as follows:
The estimates in tables 1 and 2 of this
document are based on the estimated established a goal of enrolling 15

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


No. of Annual Frequency Total Annual Hours per
FDA Worksheets2 Total Hours
Recordkeepers per Recordkeeping Records Recordkeeper

Appendices A through J 500 1 500 157 78,500

Total Burden Hours 78,500


1There are no capital costs or operating and maintenance costs associated with this collection of information.
2Or comparable documentation.

Reporting audit; names of the person(s) who 500 regulatory jurisdictions will enroll
completed the self-assessment, in the Program Standards. The reporting
Based on the number and nature of verification audit, baseline survey, burden in table 2 of this document
the items that need to be completed, baseline survey update, and action plan; includes only the time necessary to fill
FDA estimates a total of 12 minutes signature of the program manager; and out and send the forms, as compiling
annually for each enrolled jurisdiction date the form was completed. Form the underlying information (including
to complete both FDA Form 3519, ‘‘FDA 3520 requires the name of the self-assessment reports, baseline
National Registry Report,’’ and Form jurisdiction, completion date of the self surveys, outside audits, and supporting
3520, ‘‘Permission to Publish in assessment, date of the verification documentation) is accounted for under
National Registry.’’ Form 3519 requires audit report, name of the auditor,
the recordkeeping estimates in table 1 of
the name and address of the signature and title of the official
this document.
jurisdiction; completion dates for the completing the form, and date the form
self assessment, baseline survey was completed. As explained previously Thus, FDA estimates the burden for
(original and update), and verification in this document, FDA estimates that this collection of information as follows:

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
FDA Forms Total Hours
Respondents per Response Responses Response
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3519 500 1 500 6 min 50 hours

3520 500 1 500 6 min 50 hours

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66340 Federal Register / Vol. 71, No. 219 / Tuesday, November 14, 2006 / Notices

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued


No. of Annual Frequency Total Annual Hours per
FDA Forms Total Hours
Respondents per Response Responses Response

Total Burden Hours 100 hours


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

III. Comments ADDRESSES: The Department of During the meeting, the DHS Chief
Interested persons may submit to the Homeland Security Data Privacy and Privacy Officer will provide an update
Division of Dockets Management (see Integrity Advisory Committee meeting on the activities of the DHS Privacy
ADDRESSES) written or electronic
will be held in the Key Biscayne A room Office. The Subcommittees will update
comments on the draft Program of the Eden Roc Hotel, 4525 Collins the Committee on the work currently
Standards document and its Avenue, Miami Beach, Florida 33140. being conducted. In the morning and
Persons wishing to make comments or afternoon sessions, invited speakers will
recommendations for collection of
who are unable to attend or speak at the discuss data integrity and credentialing
information. Submit a single copy of
meeting may submit comments at any programs. A tentative agenda has been
electronic comments or two paper
time. All submissions received must
copies of any mailed comments, except posted on the Privacy Advisory
include the docket number: DHS–2006–
that individuals may submit one paper Committee Web site at http://
0070 and may be submitted by any one
copy. Comments are to be identified www.dhs.gov/privacy.
of the following methods:
with the docket number found in • Federal Rulemaking Portal: http:// Public comments will be accepted
brackets in the heading of this www.regulations.gov. Follow during the meeting between 2 p.m. and
document. The draft Program Standards instructions for submitting comments 2:30 p.m. All those who wish to make
document and received comments may on the Web site. public comments during this time may
be seen in the Division of Dockets • E-mail: PrivacyCommittee@dhs.gov. register in advance or sign-up on the
Management between 9 a.m. and 4 p.m., Include docket number in the subject
Monday through Friday. day of the meeting. In order to allow as
line of the message. many people as possible to testify,
IV. Electronic Access • Fax: (571) 227–4171.
witnesses should limit their remarks to
• Mail: Ms. Rebecca J. Richards,
Persons with access to the Internet Executive Director, Data Privacy and three minutes. For those wishing to
may obtain the draft Program Standards Integrity Advisory Committee, make written comments, please follow
document at http://www.cfsan.fda.gov/ Department of Homeland Security, Mail the procedure noted above.
~dms/ret3toc.html. Stop D–3, Arlington, Virginia 22202. Public attendance is encouraged. Any
Dated: October 31, 2006. Instructions: All submissions received member of the public who wishes to
Jeffrey Shuren, must include the docket number: DHS– attend the public session is requested to
Assistant Commissioner for Policy.
2006–0070. Comments received will provide his or her name and affiliation
also be posted without alteration at no later than 2 p.m. EST, Friday,
[FR Doc. E6–19195 Filed 11–13–06; 8:45 am]
www.regulations.gov, including any December 1, 2006, to Rebecca J.
BILLING CODE 4160–01–S
personal information provided. Richards via e-mail at
Docket: For access to the docket to
PrivacyCommittee@dhs.gov, or via
read background documents or
comments received by the DHS Data telephone at (571) 227–3813. This will
DEPARTMENT OF HOMELAND
Privacy and Integrity Committee, go to assist with the preparation of name
SECURITY
www.regulations.gov. Comments badges, meeting materials and seating
Office of the Secretary received will be posted without arrangements. Everyone who plans to
alteration at http://www.dhs.gov/ attend is respectfully requested to be
[DHS–2006–0070] privacy, including any personal present and seated by 7:45 a.m. for the
information provided. morning session and by 12 p.m. for the
Data Privacy and Integrity Advisory afternoon session.
FOR FURTHER INFORMATION CONTACT:
Committee
Hugo Teufel III, Chief Privacy Officer, or Persons with disabilities who require
AGENCY: Office of the Secretary, Rebecca J. Richards, Executive Director, special assistance should indicate this
Department of Homeland Security. Data Privacy and Integrity Advisory in their admittance request and are
ACTION: Notice of Federal Advisory Committee, Department of Homeland encouraged to identify anticipated
Committee Meeting. Security, Arlington, Virginia 22202, by special needs as early as possible.
telephone (571) 227–3813, by fax (571)
SUMMARY: This notice announces the 227–4171, or by e-mail Although every effort will be made to
date, time, location, and agenda for the PrivacyCommittee@dhs.gov. accommodate all members of the public,
next meeting of the Department of seating is limited and will be allocated
SUPPLEMENTARY INFORMATION: The Data
Homeland Security Data Privacy and on a first-come, first-served basis.
Privacy and Integrity Advisory
Integrity Advisory Committee. This Committee (‘‘Privacy Advisory Hugo Teufel III,
meeting will be open to the public, with Committee’’) will be meeting on Chief Privacy Officer.
the exception of a one-hour Wednesday, December 6, 2006, in the
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administrative session. [FR Doc. E6–19173 Filed 11–13–06; 8:45 am]


Key Biscayne A room of the Eden Roc
BILLING CODE 4410–10–P
DATES: The meeting will be held from 8 Hotel, 4525 Collins Avenue, Miami
a.m. to 11:15 a.m. and 12:15 p.m. to 2:30 Beach, Florida 33140. The meeting will
p.m. on Wednesday, December 6, 2006, be held from 8 a.m. to 11:15 a.m. and
in Miami Beach, Florida. 12:15 p.m. to 2:30 p.m.

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