[Federal Register: November 22, 2005 (Volume 70, Number 224)]
[Notices]
[Page 70621-70623]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no05-88]
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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:
<bullet> Whether products contain 0.5 g or less transfat;
<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
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
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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
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006 November 22, 2005