Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007; Availability; Announcement of Further Delay in Implementation of the Food and Drug Administration Amendments Act of 2007, 27803-27804 [E9-13614]
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27803
Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices
Description: The Performance
Progress Report (SF–PPR) is a set of
uniform reporting formats used for
standard reporting on performance
under grants and cooperative
agreements.
In addition to allowing for uniformity
of information collection, these formats
will support systematic electronic
collection and submission of
information. These formats will provide
interim and final performance progress
information as required by OMB
Circulars A–102 and 2 CFR part 215.
The SF–PPR consists of a cover page
and six optional formats. The cover page
contains identifying data elements and
a section for a performance narrative.
Use of the cover page is required, and
programs may require their respondents
to submit only this page and/or attach
a performance narrative. Alternatively,
programs may opt to require the cover
page and one or more of the six optional
formats: Performance Measures,
Program Indicators, Benchmark
Evaluations, Table of Activity Results,
Activity-Based Expenditures, and
Program/Project Management
The SF–PPR has been successfully
piloted at the Administration for
Children and Families (ACF). All
discretionary programs (starting with
FY09 awards) are to submit the SF–PPR
to the ACF Office of Grants
Management. Program offices with
expiring data collections are required to
migrate to the SF–PPR format.
Additionally, a number of program
offices have voluntarily migrated their
collections to the SF–PPR format in
anticipation of government-wide
standardization. ACF, with its Online
Data Collection tool (OLDC), has
provided program offices with the
capability to collect SF–PPR data
electronically.
ACF and the Grants Center of
Excellence (CoE) is sponsoring this
collection on behalf of the Grants Policy
Committee, other Federal grant-making
agencies, and the CoE partners.
CoE Partners are defined as:
Corporation for National and
Community Service,
Denali Commission,
Department of State,
DHHS/Administration on Aging,
DHHS/Centers for Medicare Services,
DHHS/Health Research and Services
Administration,
DHHS/Indian Health Services,
DHHS/Office of Public Health Services,
DOT/Federal Air Administration,
DOT/Federal Highway Administration,
DOT/Federal Motor Carrier Safety
Administration,
DOT/Federal Railroad Administration,
DOT/Federal Transport Administration,
DOT/Pipeline and Hazardous Materials
Safety Administration,
Environmental Protection Agency,
Institute of Museum and Library
Services,
Social Security Administration,
Department of Treasury,
USDA/Food Safety and Inspection
Service,
Veterans Administration.
The revised burden estimates are
based on grant projects and awards for
ACF and its CoE partners for FY2008 as
reported by internal ACF reporting
systems and USASpending.gov.
Respondents: Federal government
grantees
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
jlentini on PROD1PC65 with NOTICES
Performance Progress Report (SF–PPR) .....................................................
Cover Page Continuation (SF–PPR–2) .........................................................
Performance Measures (SF–PPR–A) ............................................................
Program Indicators (SF–PPR–B) ..................................................................
Benchmark Evaluations (SF–PPR–C) ...........................................................
Table of Activity Results (SF–PPR–D) ..........................................................
Activity Based Expenditures (SF–PPR–E) ....................................................
Program/Project Management (SF–PPR–F) .................................................
Estimated Total Annual Burden
Hours: 86,808.18
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
VerDate Nov<24>2008
16:37 Jun 10, 2009
Jkt 217001
Dated: June 8, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–13728 Filed 6–10–09; 8:45 am]
PO 00000
Average burden
hours per
response
1
1
1
1
1
1
1
1
0.42
0.33
0.75
3
1.50
0.75
0.33
0.50
131,281
86
430
8,961
248
4,238
2,616
45
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7245,
Attn: Desk Officer for the
Administration for Children and
Families.
BILLING CODE 4184–01–P
Number of
responses per
respondent
Total burden
hours
55,138.02
28.38
322.50
26,883
372
3,178.50
863.28
22.50
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0260]
Draft Guidance for Industry: Questions
and Answers Regarding the
Reportable Food Registry as
Established by the Food and Drug
Administration Amendments Act of
2007; Availability; Announcement of
Further Delay in Implementation of the
Food and Drug Administration
Amendments Act of 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Guidance for Industry: Questions and
Frm 00037
Fmt 4703
Sfmt 4703
E:\FR\FM\11JNN1.SGM
11JNN1
27804
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
VerDate Nov<24>2008
16:37 Jun 10, 2009
Jkt 217001
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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).
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Pages 27803-27804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13614]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0260]
Draft Guidance for Industry: Questions and Answers Regarding the
Reportable Food Registry as Established by the Food and Drug
Administration Amendments Act of 2007; Availability; Announcement of
Further Delay in Implementation of the Food and Drug Administration
Amendments Act of 2007
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Questions and
[[Page 27804]]
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 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 MedWatch\Plus\ 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 MedWatch\Plus\ 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 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/GuidanceComplianceRegulatoryInformation/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
