[Federal Register Volume 71, Number 68 (Monday, April 10, 2006)]
[Notices]
[Pages 18105-18106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0343]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 10, 
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.

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

    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

[[Page 18106]]

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. 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. Thus, in the Federal Register of December 14, 2005 (70 FR 
74020), FDA announced the availability of a guidance document for 
industry and FDA entitled ``Requesting an Extension to Use Existing 
Label Stock After the Trans Fat Labeling Effective Date of January 1, 
2006.'' That document 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.
    The agency intends to consider the following factors in any request 
from a firm for the agency's exercise of enforcement discretion:
     Whether products contain 0.5 g or less trans fat;
     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.
    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 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 expects that small businesses and very 
small businesses are the firms most likely to take advantage of this 
opportunity to submit a request for an extension to the trans fat 
labeling deadline. FDA estimates a 2-year time period during which 
these requests will be made following the issuance of this guidance. 
Beyond 2 years time, FDA expects businesses to fully comply with the 
trans fat labeling final rule, as it is unlikely that there will still 
be old labeling stock remaining.
    In previous Federal Register notices regarding this collection of 
information (70 FR 52108 and 70 FR 70621), the estimated number of 
requests was lower than the actual number of requests received by the 
agency in response to the guidance. Thus, we have increased the 
estimated number of requests based on FDA's recent experience. In the 
Federal Register of November 22, 2005 (70 FR 70621), FDA published a 
60-day notice requesting public comment on the information collection 
provisions. We received four comments; however, none were related to 
the information collection.
    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 600 
businesses are expected to submit written requests in year one, the 
total burden hours for year one is 3,000 hours.
    In year two, FDA expects about one-half as many businesses to 
request a labeling compliance extension. So, for year two, 300 
businesses 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 
1,500 hours.
    FDA estimates the burden of this 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
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Written requests                 600                  1                600                  5              3,000
 to FDA in year
 one
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Written requests                 300                  1                300                  5              1,500
 to FDA in year
 two
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One time burden hours for years one and two                                                                4,500
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5199 Filed 4-7-06; 8:45 am]
BILLING CODE 4160-01-S