[Federal Register Volume 70, Number 169 (Thursday, September 1, 2005)]
[Notices]
[Pages 52108-52110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0343]


Agency Emergency Processing Under Office of Management and Budget 
Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). FDA is preparing a guidance 
document to notify the public of procedures being implemented by the 
agency to assist firms that wish to request, on a case-by-case basis 
upon an appropriate showing, an extension to use existing label stock 
after the effective date of the trans fat labeling final rule. This 
notice solicits comments on the proposed collection of information 
associated with the guidance document entitled ``Guidance for 
Requesting an Extension to Use Existing Label Stock After the Trans Fat 
Labeling Effective Date of January 1, 2006.''

DATES: Fax written comments on the collection of information by October 
3, 2005. FDA is requesting approval of this emergency processing by 
September 8, 2005.

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

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. FDA issued a final rule (the 
trans fat final rule) on July 11, 2003 (68 FR 41434) to

[[Page 52109]]

require food labels to bear the gram 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 amended paragraph (c)(2) of Sec.  101.9 
Nutrition Labeling of Food (21 CFR 101.9). The effective date for the 
trans fat final rule is January 1, 2006. However, FDA has been advised 
by some businesses that they may experience hardship in revising their 
labels in time to meet the compliance date for trans fat labeling. 
Therefore, the agency believes that it would be appropriate to 
consider, on a case-by-case basis upon an appropriate showing, whether 
to exercise enforcement discretion with respect to the January 1, 2006, 
effective date for trans fat labeling for some businesses, so that 
these businesses would have the option of using some or all of their 
existing label stock that does not comply with the trans fat final 
rule.
    FDA intends to notify the public, in a level 1 guidance document 
issued under the good guidance practices regulation (21 CFR 10.115), of 
the factors it intends to consider in granting or denying such requests 
and the process businesses may use to request the agency's 
consideration for enforcement discretion on trans fat labeling 
requirements. At a later date, FDA will announce the availability of a 
guidance entitled ``Guidance for Requesting an Extension to Use 
Existing Label Stock After the Trans Fat Labeling Effective Date of 
January 1, 2006.'' The guidance will provide voluntary recommendations 
on the process for firms that wish to request an extension to use 
existing label stock after the effective date of the trans fat final 
rule.
    Because this guidance involves a collection of information, the PRA 
is implicated. However, the delay associated with normal PRA clearance 
procedures can reasonably be anticipated to prevent or disrupt the 
collection of information during a time period within which businesses 
would be most likely to make the request for the use of existing label 
stock before the effective date of January 1, 2006. As a result, given 
the need for immediate action, FDA requests emergency processing of 
this collection of information request.
    With respect to the following proposed collection of information, 
FDA invites comments on the following 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.
    Title: Guidance for Requesting an Extension to Use Existing Label 
Stock After the Trans Fat Labeling Effective Date of January 1, 2006.
    Description: This policy provides guidance to FDA and the food 
industry about when and how businesses may request that the agency 
consider enforcement discretion for the use of some or all existing 
label stock, that does not declare trans fat labeling in compliance 
with the trans fat 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

    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 
from a firm for the agency's exercise of enforcement discretion:
    <bullet> Whether products contain 0.5 gram or less trans fat;
    <bullet> The explanation of why the request is being made;
    <bullet> The number of existing labels that the firm is requesting 
to use;
    <bullet> The dollar amount associated with the number of existing 
labels to be used; and
    <bullet> 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 
officer or employee of the FDA 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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                                               Annual
       Activity              No. of         Frequency per     Total Annual        Hours per        Total Hours
                           Respondents        Response          Responses         Response
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Written requests to                   56                 1                56                 5               280
 FDA in year one
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Written requests to                   28                 1                28                 5               140
 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.

[[Page 52110]]

    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 label 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 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: August 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17413 Filed 8-29-05; 2:49 pm]
BILLING CODE 4160-01-S