Reportable Food Registry as Required by the Food and Drug Administration Amendments Act of 2007; Announcement of Delay in Implementation and Request for Comments, 30405-30406 [E8-11517]
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Federal Register / Vol. 73, No. 102 / Tuesday, May 27, 2008 / Notices
exist that justify the waiver or
reduction.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Audit Implementation
Food and Drug Administration
(1) Enforcement Condition: Awardees
who fail to submit the required audit or
spend amounts in noncompliance.
(2) Enforcement Action: Grants
Management Officer disallows costs and
requests payment via standard audit
disallowance process or temporarily
withholds funds pending corrective
action.
Adjudication: Enforcement will be in
accordance with 45 Code of Federal
Regulation (CFR), part 16.
[Docket No. FDA–2008–N–0298]
Carryover
(1) Enforcement Condition: For each
fiscal year, the percentage amount of an
award unexpended by an awardee
exceeds the maximum percentage
permitted by the Secretary.
(2) Enforcement Action: Awardees
shall return to the Secretary the portion
of the unexpended amount that exceeds
the maximum permitted to be carried
over. According to Public Law 109–417,
any funds withheld from the PHEP or
the Hospital Preparedness Program will
be reallocated to the Healthcare
Facilities Partnership program in the
same state.
Waive or Reduce: The awardee may
request a waiver of the maximum
percentage amount or the Secretary may
waive or reduce the withholding as
described above for a single entity or for
all entities in a fiscal year, if the
Secretary determines that mitigating
conditions exist that justify the waiver
or reduction. The Secretary will make a
decision after reviewing the awardee’s
request for waiver.
The Department of Health and Human
Services (HHS) permits grantees to
appeal to the Departmental Appeal
Board (DAB) certain post-award adverse
administrative decisions made by HHS
officials (see 45 CFR part 16). CDC has
established a first-level grant appeal
procedure that must be exhausted before
an appeal may be filed with the DAB
(see 42 CFR part 50.404). CDC will
assume jurisdiction for any of the above
adverse determinations.
[FR Doc. E8–11718 Filed 5–23–08; 8:45 am]
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Jkt 214001
Reportable Food Registry as Required
by the Food and Drug Administration
Amendments Act of 2007;
Announcement of Delay in
Implementation and Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; delay in implementation
and request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
delay in the implementation of the
Reportable Food Registry (the Registry)
of the Food and Drug Administration
Amendments Act of 2007 (FDAAA).
FDA intends to implement the FDAAA
requirement to establish an electronic
portal for reportable food by utilizing
the business enterprise system currently
under development by the agency. This
system will be easy to use and the most
efficient and cost effective for both users
and the agency. FDA expects that the
agency’s business enterprise system will
be operational in spring 2009. FDA
acknowledges that the prohibited act
provisions relating to the Registry will
not apply until such time as FDA
establishes the electronic portal to
implement the Registry. In conjunction
with this delay announcement, FDA is
requesting comments on certain aspects
of the Registry provisions.
DATES: Submit written or electronic
comments by August 11, 2008.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
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:
FOR FURTHER INFORMATION CONTACT:
I. Background
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). Section 417
of the act requires the Secretary of
Health and Human Services (the
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
30405
Secretary) 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). The
Congressionally-identified purpose of
the Registry is to provide a ‘‘reliable
mechanism to track patterns of
adulteration in food [which] would
support efforts by the Food and Drug
Administration to target limited
inspection resources to protect the
public health’’ (121 Stat. 965). The
Secretary has delegated to the
Commissioner of Food and Drugs the
responsibility for administering the act,
including section 417 of the act.
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 may be submitted to FDA by
responsible parties or public health
officials.
Section 417(a)(1) of the act defines
‘‘responsible party’’ as a person that
submits the registration under section
415(a) of the act (21 U.S.C. 350d) for a
food facility that is required to register
under section 415(a), at which such
article of food is manufactured,
processed, packed, or held. Persons who
are authorized to submit a facility
registration under section 415 of the act
are the owner, operator, or agent in
charge of a domestic or foreign facility
engaged in manufacturing, processing,
packing, or holding food for
consumption in the United States.
Section 417(a)(2) of the act defines a
‘‘reportable food’’ as an article of food
(other than infant formula) for which
there is a reasonable probability that the
use of, or exposure to, such article of
food will cause serious adverse health
consequences or death to humans or
animals.
Under section 417(d) of the act, a
responsible party is required to submit
a report to FDA through the Reportable
Food electronic portal as soon as
practicable, but in no case later than 24
hours after the responsible party
determines that an article of food is a
reportable food. Federal, State, and local
public health officials may voluntarily
submit such reports to FDA through the
electronic portal under section 417(d)(3)
of the act. Section 417(e) of the act
specifies 11 data elements that are
required in the initial report or in a
subsequent report to FDA; such reports
are to be submitted via the Reportable
Food electronic portal. Examples of
required data elements include the
following: (1) The registration numbers
E:\FR\FM\27MYN1.SGM
27MYN1
30406
Federal Register / Vol. 73, No. 102 / Tuesday, May 27, 2008 / Notices
pwalker on PROD1PC71 with NOTICES
of the responsible party provided under
section 415(a)(3) of the act; (2) the date
on which the article of food was
determined to be a reportable food; and
(3) a description of the article of food
including the quantity or amount.
Section 417(b)(2) of the act requires
FDA to review promptly and assess
information submitted via the electronic
portal. Section 417(c)(1) requires FDA to
issue, or cause to be issued, an alert or
notification with respect to a reportable
food using the information from the
Registry as FDA deems necessary to
protect the public health. In addition,
following submission of a report via the
Reportable Food electronic portal and
after consultation with the responsible
party that submitted a report, FDA may
require the responsible party to provide
a notification consistent with section
417(d)(6)(B) of the act. Section 1005(e)
of FDAAA provides that the
requirements of section 417(d) of the act
are effective 1 year after the enactment
date (i.e., on September 27, 2008). The
failure to submit a report or provide a
notification required by section 417(d)
of the act is a prohibited act under
section 301(mm) of the act (21 U.S.C.
331(mm)); persons who commit a
prohibited act may be enjoined (21
U.S.C. 332) or prosecuted criminally (21
U.S.C. 333).
Under section 1005(f) of FDAAA,
FDA is required to issue a guidance to
industry about submitting reports to the
electronic portal established under
section 417(b)(1) of the act and
providing notifications to other persons
in the supply chain of an article of food.
This guidance is required to be issued
not later than 9 months after the date of
enactment of FDAAA (i.e., by June 27,
2008).
II. Delay in Implementation of the
Registry
FDA has determined that the most
efficient and cost effective means of
implementing the requirements of
section 417 of the act relating to the
Registry is to utilize the business
enterprise system currently under
development within the agency. This
system will permit FDA to establish an
electronic portal through which
instances of reportable food may be
submitted to the agency, and will be
easy to use, for both those submitting
reports to the agency and for FDA.
However, the agency anticipates that
FDA’s business enterprise system will
not be implemented in time to meet the
statutory deadline of section 417(b)(1) of
the act which, as stated, requires FDA
to establish the Reportable Food
electronic portal by September 27, 2008.
Therefore, FDA is announcing a delay in
VerDate Aug<31>2005
17:22 May 23, 2008
Jkt 214001
the implementation of the requirements
of section 417 of the act.
FDA expects that the agency’s
business enterprise system will be
operational in spring 2009. In a future
issue of the Federal Register, the agency
will notify the public, including the
industry, of the date the Reportable
Food electronic portal becomes
available to accept reports under section
417(d) of the act. After that date, FDA
expects that responsible parties will
comply with the requirements of section
417 of the act, including the
requirement to submit instances of
reportable food to the agency via the
Reportable Food electronic portal. 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. Request for Comments
FDA is seeking comments on the
requirements contained in the Registry
provisions of section 417 of the act. In
addition to general information, data,
and comments, we request comments on
the following questions:
(1) What obstacles, if any, do
responsible parties anticipate in
complying with the requirements of
section 417 of the act?
(2) How can FDA enhance the quality,
utility, and clarity of the information to
be submitted to the Registry?
(3) What would be an efficient and
effective method for providing and
receiving notifications to and from
sources and recipients in the supply
chain of instances of reportable food?
(4) In addition to the data elements set
out in section 417 of the act, what other
information, if any, would be important
to provide in responsible party
notifications to the immediate previous
source and immediate subsequent
recipient of the article of food?
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.
Please note that on January 15, 2008,
the FDA Division of Dockets
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: May 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–11517 Filed 5–23–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 73 FR 22961–22964
dated April 28, 2008).
This notice reflects organizational
changes in the Health Resources and
Services Administration. Specifically,
this notice updates the functional
statement for the Office of Information
Technology (RAG).
Chapter RA—Office of the
Administrator
Section RA–10, Organization
The Office of the Administrator (RA)
is headed by the Administrator, Health
Resources and Services Administration,
who reports directly to the Secretary.
The OA includes the following
components:
(1) Immediate Office of the
Administrator (RA);
(2) Office of Equal Opportunity and
Civil Rights (RA2);
(3) Office of Planning and Evaluation
(RA5);
(4) Office of Communications (RA6);
(5) Office of Minority Health and
Health Disparities (RA9);
(6) Office of Legislation (RAE);
(7) Office of Information Technology
(RAG);
(8) Office of International Health
Affairs (RAH); and
(9) Office of Management (RAM).
Section RAG–20, Functions
Delete the current functional
statement for the Office of Information
E:\FR\FM\27MYN1.SGM
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Agencies
[Federal Register Volume 73, Number 102 (Tuesday, May 27, 2008)]
[Notices]
[Pages 30405-30406]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11517]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0298]
Reportable Food Registry as Required by the Food and Drug
Administration Amendments Act of 2007; Announcement of Delay in
Implementation and Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; delay in implementation and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a delay
in the implementation of the Reportable Food Registry (the Registry) of
the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA
intends to implement the FDAAA requirement to establish an electronic
portal for reportable food by utilizing the business enterprise system
currently under development by the agency. This system will be easy to
use and the most efficient and cost effective for both users and the
agency. FDA expects that the agency's business enterprise system will
be operational in spring 2009. FDA acknowledges that the prohibited act
provisions relating to the Registry will not apply until such time as
FDA establishes the electronic portal to implement the Registry. In
conjunction with this delay announcement, FDA is requesting comments on
certain aspects of the Registry provisions.
DATES: Submit written or electronic comments by August 11, 2008.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.regulations.gov.
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
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).
Section 417 of the act requires the Secretary of Health and Human
Services (the Secretary) 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).
The Congressionally-identified purpose of the Registry is to provide a
``reliable mechanism to track patterns of adulteration in food [which]
would support efforts by the Food and Drug Administration to target
limited inspection resources to protect the public health'' (121 Stat.
965). The Secretary has delegated to the Commissioner of Food and Drugs
the responsibility for administering the act, including section 417 of
the act.
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 may be submitted to FDA by responsible parties or public health
officials.
Section 417(a)(1) of the act defines ``responsible party'' as a
person that submits the registration under section 415(a) of the act
(21 U.S.C. 350d) for a food facility that is required to register under
section 415(a), at which such article of food is manufactured,
processed, packed, or held. Persons who are authorized to submit a
facility registration under section 415 of the act are the owner,
operator, or agent in charge of a domestic or foreign facility engaged
in manufacturing, processing, packing, or holding food for consumption
in the United States. Section 417(a)(2) of the act defines a
``reportable food'' as an article of food (other than infant formula)
for which there is a reasonable probability that the use of, or
exposure to, such article of food will cause serious adverse health
consequences or death to humans or animals.
Under section 417(d) of the act, a responsible party is required to
submit a report to FDA through the Reportable Food electronic portal as
soon as practicable, but in no case later than 24 hours after the
responsible party determines that an article of food is a reportable
food. Federal, State, and local public health officials may voluntarily
submit such reports to FDA through the electronic portal under section
417(d)(3) of the act. Section 417(e) of the act specifies 11 data
elements that are required in the initial report or in a subsequent
report to FDA; such reports are to be submitted via the Reportable Food
electronic portal. Examples of required data elements include the
following: (1) The registration numbers
[[Page 30406]]
of the responsible party provided under section 415(a)(3) of the act;
(2) the date on which the article of food was determined to be a
reportable food; and (3) a description of the article of food including
the quantity or amount.
Section 417(b)(2) of the act requires FDA to review promptly and
assess information submitted via the electronic portal. Section
417(c)(1) requires FDA to issue, or cause to be issued, an alert or
notification with respect to a reportable food using the information
from the Registry as FDA deems necessary to protect the public health.
In addition, following submission of a report via the Reportable Food
electronic portal and after consultation with the responsible party
that submitted a report, FDA may require the responsible party to
provide a notification consistent with section 417(d)(6)(B) of the act.
Section 1005(e) of FDAAA provides that the requirements of section
417(d) of the act are effective 1 year after the enactment date (i.e.,
on September 27, 2008). The failure to submit a report or provide a
notification required by section 417(d) of the act is a prohibited act
under section 301(mm) of the act (21 U.S.C. 331(mm)); persons who
commit a prohibited act may be enjoined (21 U.S.C. 332) or prosecuted
criminally (21 U.S.C. 333).
Under section 1005(f) of FDAAA, FDA is required to issue a guidance
to industry about submitting reports to the electronic portal
established under section 417(b)(1) of the act and providing
notifications to other persons in the supply chain of an article of
food. This guidance is required to be issued not later than 9 months
after the date of enactment of FDAAA (i.e., by June 27, 2008).
II. Delay in Implementation of the Registry
FDA has determined that the most efficient and cost effective means
of implementing the requirements of section 417 of the act relating to
the Registry is to utilize the business enterprise system currently
under development within the agency. This system will permit FDA to
establish an electronic portal through which instances of reportable
food may be submitted to the agency, and will be easy to use, for both
those submitting reports to the agency and for FDA. However, the agency
anticipates that FDA's business enterprise system will not be
implemented in time to meet the statutory deadline of section 417(b)(1)
of the act which, as stated, requires FDA to establish the Reportable
Food electronic portal by September 27, 2008. Therefore, FDA is
announcing a delay in the implementation of the requirements of section
417 of the act.
FDA expects that the agency's business enterprise system will be
operational in spring 2009. In a future issue of the Federal Register,
the agency will notify the public, including the industry, of the date
the Reportable Food electronic portal becomes available to accept
reports under section 417(d) of the act. After that date, FDA expects
that responsible parties will comply with the requirements of section
417 of the act, including the requirement to submit instances of
reportable food to the agency via the Reportable Food electronic
portal. 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. Request for Comments
FDA is seeking comments on the requirements contained in the
Registry provisions of section 417 of the act. In addition to general
information, data, and comments, we request comments on the following
questions:
(1) What obstacles, if any, do responsible parties anticipate in
complying with the requirements of section 417 of the act?
(2) How can FDA enhance the quality, utility, and clarity of the
information to be submitted to the Registry?
(3) What would be an efficient and effective method for providing
and receiving notifications to and from sources and recipients in the
supply chain of instances of reportable food?
(4) In addition to the data elements set out in section 417 of the
act, what other information, if any, would be important to provide in
responsible party notifications to the immediate previous source and
immediate subsequent recipient of the article of food?
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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: May 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11517 Filed 5-23-08; 8:45 am]
BILLING CODE 4160-01-S