[Federal Register Volume 71, Number 67 (Friday, April 7, 2006)]
[Notices]
[Pages 17892-17893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5088]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0457]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Substances Generally 
Recognized as Safe: Notification Procedure

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 8, 
2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Substances Generally Recognized as Safe: Notification Procedure (OMB 
Control Number 0910-0342)--Extension

    Section 409 of the act (21 U.S.C. 348) establishes a premarket 
approval requirement for ``food additives;'' section 201(s) of the act 
(21 U.S.C. 321(s)) provides an exemption from the definition of ``food 
additive'' and thus from the premarket approval requirement, for uses 
of substances that are generally recognized as safe (GRAS) by qualified 
experts. FDA is proposing a voluntary procedure whereby members of the 
food industry who determine that use of a substance satisfies the 
statutory exemption may notify FDA of that determination. The notice 
would include a detailed summary of the data and information that 
support the GRAS determination, and the notifier would maintain a 
record of such data and information. FDA would make the information 
describing the GRAS claim, and the agency's response to the notice, 
available in a publicly accessible file; the entire GRAS notice would 
be publicly available consistent with the Freedom of Information Act 
(FOIA) and other Federal disclosure statutes.
    In the Federal Register of December 8, 2005 (70 FR 73009), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions to which one comment was received. The comment 
states that obtaining the entire GRAS notification through the 
provisions of FOIA is not a practical means for interested persons to 
learn about the safety of a substance. The comment suggests that, to 
enhance the quality, utility, and clarity of the information to be 
collected, FDA should make publicly available a summary of data and 
information that supports the GRAS notice and also contains a 
discussion of any negative or inconsistent data.
    FDA does not agree that obtaining information through the 
provisions of FOIA is impractical for interested persons. FDA also 
disagrees with the comment's suggestion that the agency make publicly 
available in the GRAS notification process a summary of data and 
information that supports the GRAS notice and also contains a 
discussion of any negative or inconsistent data, because such a summary 
would be duplicative of information available through FOIA procedures. 
This information collection is associated with the proposed rule 
entitled ``Notice of a Claim for GRAS Exemption Based on a GRAS 
Determination'' (the proposed rule) (62 FR 18938). Proposed Sec.  
170.36(c)(4) describes requirements for a detailed summary in the GRAS 
notification procedures. This section states that notifiers shall 
submit a detailed summary of the basis for the notifier's determination 
that a particular use of the notified substance is exempt from the 
premarket approval requirements of the act because such use is GRAS. 
Such determination may be based either on scientific procedures or on 
common use in food. Proposed Sec.  170.36(c)(4)(i)(B) and 
170.36(c)(4)(ii)(B) state that this detailed summary shall contain a 
comprehensive discussion of any reports of investigations or other 
information that may appear to be inconsistent with the GRAS 
determination. Proposed Sec.  170.36(f)(1) states that all remaining 
data and information in the GRAS notice shall be available for public 
disclosure, in accordance with the provisions of FOIA, on the date the 
notice is received. This would include the detailed summary of the 
basis for the notifier's GRAS determination. To the extent that the 
comment suggests a change to the requirements of the proposed rule, FDA 
responds that such a request is outside the scope of the four 
collection of information topics on which the notice solicits comments 
and, thus, will not be addressed in this document. In response to the 
request for comments in that proposed rule, the commenter timely filed 
a similar comment. This comment will be considered in the development 
of the final rule.
    Description of Respondents: Manufacturers of Substances Used in 
Food and Feed.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 17893]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual frequency       Total annual        Hours per
                    21 CFR Section                         respondents         per response          responses           response         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.36                                                                 50                     1                 50                150              7,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
570.36                                                                 10                     1                 10                150              1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                              9,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       Annual frequency per     Total annual        Hours per
                    21 CFR Section                        recordkeepers        recordkeeping          records          recordkeeper       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.36(c)(v)                                                           50                     1                 50                 15                750
--------------------------------------------------------------------------------------------------------------------------------------------------------
570.36(c)(v)                                                           10                     1                 10                 15                150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                900
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting requirement is for a proposed rule that has not yet 
been issued as a final rule. In developing the proposed rule, FDA 
solicited input from representatives of the food industry on the 
reporting requirements, but could not fully discuss with those 
representatives the details of the proposed notification procedure. FDA 
received no comments on the agency's estimate of the hourly reporting 
requirements, and thus has no basis to revise that estimate at this 
time. In 1998, FDA began receiving notices that were submitted under 
the terms of the proposed rule. Since it began receiving notices, FDA 
has received 12 in 1998, 23 in 1999, 30 in 2000, 28 in 2001, 26 in 
2002, 23 in 2003, 20 in 2004, and 22 to date in 2005, notices annually. 
To date, the number of annual notices is less than FDA's estimate; 
however, the number of annual notices could increase when the proposed 
rule becomes final.

    Dated: April 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5088 Filed 4-6-06; 8:45 am]
BILLING CODE 4160-01-S