[Federal Register Volume 73, Number 102 (Tuesday, May 27, 2008)]
[Notices]
[Pages 30405-30406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11517]


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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.

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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 http://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 http://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