[Federal Register Volume 70, Number 224 (Tuesday, November 22, 2005)]
[Notices]
[Pages 70621-70623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0343]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Requesting an Extension to Use Existing 
Label Stock After the Trans Fat Labeling Effective Date of January 1, 
2006

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the proposed collection of 
information associated with the guidance document entitled ``Requesting 
an Extension to Use Existing Label Stock After the Trans Fat Labeling 
Effective Date of January 1, 2006.'' Elsewhere in this issue of the 
Federal Register, FDA is publishing a notice announcing the Office of 
Management and Budget (OMB's) approval of this collection of 
information (OMB control number 0910-0571). Since this was an emergency 
approval that expires on January 1, 2006, FDA is following the normal 
PRA clearance procedures by issuing this notice.

DATES: Submit written or electronic comments on the collection of 
information by January 23, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

[[Page 70622]]


SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from OMB for each collection of 
information they conduct or sponsor. ``Collection of information'' is 
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information, including each proposed 
extension of an existing collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Guidance for Requesting an Extension to Use Existing Label Stock After 
the Trans Fat Labeling Effective Date of January 1, 2006 (OMB Control 
Number 0910-0571)--Extension

    This policy provides guidance to FDA and the food industry about 
when and how businesses may request the agency to consider enforcement 
discretion for the use of some or all existing label stock, that does 
not declare trans fat labeling in compliance with the final rule, on 
products introduced into interstate commerce on or after the January 1, 
2006, effective date.
Industry Compliance With the Trans Fat Final Rule
    FDA issued a final rule (the trans fat final rule) on July 11, 
2003, (68 FR 41434) to require food labels to bear the gram (g) amount 
of trans fat without a percent Daily Value (% DV)directly under the 
saturated fat line on the Nutrition Facts panel (http://
www.cfsan.fda.gov/~acrobat/fr03711a.pdf). The trans fat final rule 
affects almost all manufacturers of packaged, labeled food sold in the 
United States. FDA believes that most businesses, including small 
businesses, should not have difficulty meeting the January 1, 2006, 
effective date of the trans fat final rule. However, under certain 
circumstances some businesses may want to request that the agency 
consider an extension of time to use current labels that are not in 
compliance with the trans fat final rule. Therefore, the agency 
believes that it would be appropriate to consider, on a case-by-case 
basis, whether to exercise enforcement discretion on the January 1, 
2006, effective date for trans fat labeling for some businesses that 
can make an appropriate showing.
    The agency intends to consider the following factors in any request 
froma firm for the agency's exercise of enforcement discretion:
     Whether products contain 0.5 g or less transfat;
     The explanation of why the request is being made;
     The number of existing labels that the firm is requesting 
to use;
     The dollar amount associated with the number of existing 
labels to be used; and
     The estimate of the amount of time needed, not exceeding 
12 months, to exhaust the number of existing labels the firm is 
requesting to use.
    Requests may be considered at any time before or after the January 
1, 2006, effective date of the trans fat final rule. Firms may submit 
their requests in writing to FDA's Center for Food Safety and Applied 
Nutrition. Firms are encouraged to keep this letter of request for 
their records and should make a copy available for inspection to any 
FDA officer or employee of who requests it. FDA intends to use the 
information in the letter to make decisions about whether a firm's 
product is subject to FDA's enforcement discretion for the trans fat 
labeling requirements.
    FDA estimates the burden of the collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
     Activity         Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Written requests                  56                  1                 56                  5                280
 to FDA in year
 one
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Written requests                  28                  1                 28                  5                140
 to FDA in year
 two
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Onetime burden hours for years one and two                                                                   420
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates a 2-year time period during which these requests will 
be made following the issuance of this guidance. Beyond 2 years, FDA 
expects businesses to fully comply with the trans fat final rule, as it 
is unlikely that there will still be old labeling stock left to use.
    FDA expects that, although all sizes of business are eligible, 
small businesses and very small businesses are the firms most likely to 
be able to demonstrate a need to request an extension to the trans fat 
labeling deadline. The agency has already received three requests from 
businesses regarding the trans fat labeling compliance date of January 
1, 2006. Because small businesses are more likely to submit requests 
for extensions, and most of the affected businesses are small, we use 
the number of small businesses as the base to calculate the reporting 
burden. The regulatory flexibility analysis of the trans fat final rule 
estimated that 11,180 small businesses will have to revise the labels 
on their products as a result of the trans fat final rule. Given that 
only three businesses have submitted requests to FDA so far, FDA 
estimates that, in the first year following the issuance of the 
guidance, the total number of businesses that will request a labeling 
compliance extension from FDA can be estimated as approximately 0.5 
percent of the number of small businesses, which equals 56.
    FDA estimates that it will take one employee approximately 4 hours 
to put together a request to FDA and approximately 1 hour for a 
supervisor to look over the request before submitting

[[Page 70623]]

 it to the agency. Thus, each firm submitting a compliance extension 
request will need 5 hours of employee time to complete the request. 
Given that 56 businesses are expected to submit written requests in 
year one, the total burden hours for year one are 280.
    In year two, FDA expects about one-half as many firms to request a 
labeling compliance extension. So for year two, 28 firms are expected 
to file a request for an extension to the labeling compliance date. 
Again, assuming that it will take 5 hours to complete each request, the 
total burden hours for year two will be 140.

    Dated: November 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23040 Filed 11-21-05; 8:45 am]
BILLING CODE 4160-01-S