Draft Guideline for Prevention of Catheter-Associated Urinary Tract Infections 2008 [Correction], 27804-27805 [E9-13694]
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Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices
jlentini on PROD1PC65 with NOTICES
Answers Regarding the Reportable Food
Registry as Established by the Food and
Drug Administration Amendments Act
of 2007.’’ The draft guidance, when
finalized, will assist the industry in
complying with the Reportable Food
Registry requirements prescribed by the
Food and Drug Administration
Amendments Act of 2007 (FDAAA).
FDA is also announcing a further delay
in the implementation of the Reportable
Food Registry (the Registry) of FDAAA
until September 8, 2009, to consider any
comments received on the draft
guidance and through the agency’s
planned outreach initiatives, and to
allow for further testing of the electronic
portal for reportable foods.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on the draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by July 27, 2009.
ADDRESSES: Submit written comments
on the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
requests for single copies of the draft
guidance to the Office of Food Defense,
Communication and Emergency
Response, Center for Food Safety and
Applied Nutrition (HFS–005), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Faye
Feldstein, Center for Food Safety and
Applied Nutrition (HFS–005), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–2428.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance entitled ‘‘Guidance for
Industry: Questions and Answers
Regarding the Reportable Food Registry
as Established by the Food and Drug
Administration Amendments Act of
2007.’’ The draft guidance is intended to
assist those parties responsible for
complying with the Reportable Food
Registry requirements prescribed by
FDAAA.
FDA is issuing this draft guidance as
a level 1 draft guidance consistent with
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FDA’s good guidance practices
regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent
the agency’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternate approach may be used if such
approach satisfies the requirements of
the applicable statutes and regulations.
II. Notice of Further Delay in
Implementation
On September 27, 2007, the President
signed FDAAA into law (Public Law
110–85). Section 1005 of FDAAA
amends the Federal Food, Drug, and
Cosmetic Act (the act) by creating a new
section 417 (21 U.S.C. 350f), among
other things. Section 417 of the act
requires the Secretary of Health and
Human Services to establish within
FDA a Reportable Food Registry (the
Registry); the Registry is to be
established not later than 1 year after
the date of enactment (i.e., by
September 27, 2008).
To further the development of the
Registry, section 417 of the act requires
FDA to establish, also within 1 year
after the date of enactment (i.e., by
September 27, 2008), an electronic
portal (the Reportable Food electronic
portal) by which instances of reportable
food must be submitted to FDA by
responsible parties and may be
submitted by public health officials.
FDA made the decision that the most
efficient and cost effective means to
implement the requirements of section
417 of the act relating to the Registry
was to utilize the business enterprise
system currently under development
within the agency: the MedWatchPlus
Portal. This would permit the agency to
establish an electronic portal through
which instances of reportable food may
be submitted to the agency. However,
FDA recognized that the MedWatchPlus
Portal would not be implemented in
time to meet the September 27, 2008,
deadline for establishing the Reportable
Food electronic portal and therefore
announced that it was delaying its
implementation until spring 2009 (73
FR 30405; May 27, 2008).
The agency now expects the system to
be operational on September 8, 2009,
and is therefore announcing that the
implementation of the requirements of
section 417 of the act will be further
delayed until September 8, 2009.
In the interim, FDA strongly
encourages persons to continue to report
instances of adulterated food through
existing mechanisms, such as notifying
the relevant FDA District office, until
such time as the Registry and its
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associated electronic portal are fully
implemented.
III. Paperwork Reduction Act of 1995
This draft guidance document
contains a collection of information that
requires clearance by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FDA intends to submit the collection of
information to OMB in the near future
for emergency processing. At that time,
the agency will publish a notice in the
Federal Register soliciting comments on
the collection of information.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in
question 28 of the guidance have been
approved under OMB control no. 0910–
0249.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/Food/Guidance
ComplianceRegulatoryInformation/
GuidanceDocuments/default.htm or
https://www.regulations.gov.
Dated: June 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–13614 Filed 6–10–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Draft Guideline for Prevention of
Catheter-Associated Urinary Tract
Infections 2008 [Correction]
The notice ‘‘Draft Guideline for
Prevention of Catheter-Associated
Urinary Tract Infections 2008,’’ was
published in the Federal Register on
June 3rd, 2009, (Vol. 74 FR No. 105).
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Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices
This notice is corrected as follows: On
page 26704 first column, under
SUMMARY, the Web site should read:
https://wwwn.cdc.gov/publiccomments/.
Dated: June 4, 2009.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–13694 Filed 6–10–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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.
jlentini on PROD1PC65 with NOTICES
Name of Committee: National Institute of
General Medical Sciences; Initial Review
Group Minority Programs Review,
Subcommittee B.
Date: July 9–10, 2009.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, Bethesda, MD 20814.
Contact Person: Rebecca H. Johnson, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18C, Bethesda,
MD 20892. 301–594–2771.
Johnsonrhnigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
27805
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and
Prevention
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; MBRS SCORE.
Date: July 9, 2009.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Room 3AN12, 45 Center
Drive, Bethesda, MD 20892 (Telephone
Conference Call)
Contact Person: Arthur L. Zachary, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN–12, Bethesda,
MD 20892, (301) 594–2886,
zacharya@nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: June 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–13758 Filed 6–10–09; 8:45 am]
BILLING CODE 4140–01–M
Board of Scientific Counselors,
Coordinating Center for Health
Promotion (BSC, CCHP)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
Time and Date: 8:30 a.m.–5 p.m., July 1,
2009.
Place: CDC, 1825 Century Boulevard, NE.,
Room 1042, Atlanta, Georgia 30345.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 75 people.
Purpose: This BSC is charged with
providing advice and guidance to the
Secretary of Health and Human Services, the
Director of CDC, and the Director of CCHP
concerning strategies and goals for the
programs and research within the National
Center on Birth Defects and Developmental
Disabilities and the National Center for
Chronic Disease Prevention and Health
Promotion.
Matters To Be Discussed: The agenda will
include a review and discussion of charges
to the BSC Work Groups. The Work Group
projects include strategic planning and
procedures for future external peer review of
programs in the National Center on Birth
Defects and Developmental Disabilities, and
the National Center for Chronic Disease
Prevention and Health Promotion. The BSC
will also discuss results of its review of the
National Center for Chronic Disease
Prevention and Health Promotion as an
organizational unit at CDC.
Providing Oral or Written Comments: It is
the policy of the BSC, CCHP to provide a
brief period for oral public comments. In
general, each individual or group requesting
to make an oral presentation will be limited
to a total time of five minutes if time permits.
Contact Person for Additional Information:
Karen Steinberg, PhD, Senior Science Officer,
Coordinating Center for Health Promotion,
CDC, 4770 Buford Highway, NE., Mailstop E–
70, Atlanta, Georgia 30341; telephone (404)
498–6700; fax (404) 498–6880; or via e-mail
at Karen.Steinberg@cdc.hhs.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities, for
CDC and the Agency for Toxic Substances
and Disease Registry.
Dated: June 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–13757 Filed 6–10–09; 8:45 am]
Dated: June 4, 2009.
Lorenzo Falgiano,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E9–13692 Filed 6–10–09; 8:45 am]
BILLING CODE 4140–01–M
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Agencies
[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Pages 27804-27805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13694]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Draft Guideline for Prevention of Catheter-Associated Urinary
Tract Infections 2008 [Correction]
The notice ``Draft Guideline for Prevention of Catheter-Associated
Urinary Tract Infections 2008,'' was published in the Federal Register
on June 3rd, 2009, (Vol. 74 FR No. 105).
[[Page 27805]]
This notice is corrected as follows: On page 26704 first column, under
SUMMARY, the Web site should read: https://wwwn.cdc.gov/publiccomments/.
Dated: June 4, 2009.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-13694 Filed 6-10-09; 8:45 am]
BILLING CODE 4163-18-P