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, 70621-70623 [05-23040]
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Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Notices
70621
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Attn: Desk Officer for
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
Dated: November 16, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–23084 Filed 11–21–05; 8:45 am]
AGENCY:
BILLING CODE 4184–01–M
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Regulations For In Vivo
Radiopharmaceuticals Used For
Diagnosis and Monitoring’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Invitation to Comment on Proposed
Data Composites and Potential
Performance Areas and Measures for
the Child and Family Services Review
AGENCY: Children’s Bureau (CB),
Administration on Children, Youth and
Families (ACYF), Administration for
Children and Families (ACF),
Department of Health and Human
Services.
[Docket No. 2005N–0343]
[Docket No. 2005N–0153]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Regulations for In Vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring
Food and Drug Administration,
HHS.
ACTION:
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
Corrective Action: The initial
publication in the Federal Register on
November 7, 2005 (70 FR 67479)
inadvertently omitted the date that the
comments are due to the Children’s
Bureau. The due date for comments is
December 7, 2005.
Dated: November 17, 2005.
Reginia H. Ryan,
Director, Executive Secretariat, ACYF.
[FR Doc. 05–23206 Filed 11–21–05; 8:45 am]
Dated: November 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23039 Filed 11–21–05; 8:45 am]
Correction notice to the
following action: Invitation to comment
on proposed data composites and
potential performance areas and
measures for the Federal Child and
Family Services Review (CFSR).
VerDate Aug<31>2005
17:22 Nov 21, 2005
SUPPLEMENTARY INFORMATION:
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AGENCY:
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Food and Drug Administration,
HHS.
ACTION:
Notice.
In the
Federal Register of May 3, 2005 (70 FR
22887), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0409. The
approval expires on October 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
ACTION:
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
Notice.
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: https://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.
E:\FR\FM\22NON1.SGM
22NON1
70622
Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Notices
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,
SUPPLEMENTARY INFORMATION:
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 (https://
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-bycase 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 BURDEN1
No. of
Respondents
Activity
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Written requests to FDA in year one
56
1
56
5
280
Written requests to FDA in year two
28
1
28
5
140
Onetime burden hours for years one and two
1There
420
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
VerDate Aug<31>2005
18:49 Nov 21, 2005
Jkt 208001
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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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
E:\FR\FM\22NON1.SGM
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Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Notices
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 onehalf 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]
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0571. The
approval expires on January 31, 2006. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: November 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23041 Filed 11–21–05; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Food and Drug Administration
Advisory Commission on Childhood
Vaccines; Notice of Meeting
[Docket No. 2005N–0343]
70623
Administration (HRSA), Room 11C–26, 5600
Fishers Lane, Rockville, Maryland 20857 or
e-mail clee@hrsa.gov. Requests should
contain the name, address, telephone
number, and any business or professional
affiliation of the person desiring to make an
oral presentation. Groups having similar
interests are requested to combine their
comments and present them through a single
representative. The allocation of time may be
adjusted to accommodate the level of
expressed interest. DVIC will notify each
presenter by mail or telephone of their
assigned presentation time. Persons who do
not file an advance request for a presentation,
but desire to make an oral statement, may
announce it at the time of the comment
period. These persons will be allocated time
as it permits.
For Further Information Contact: Anyone
requiring information regarding the ACCV
should contact Ms. Cheryl Lee, Principal
Staff Liaison, DVIC, HSB, HRSA, Room 11C–
26, 5600 Fishers Lane, Rockville, MD 20857;
telephone (301) 443–2124 or e-mail
clee@hrsa.gov.
Dated: November 15, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–23042 Filed 11–21–05; 8:45 am]
BILLING CODE 4165–15–P
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
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Requesting an Extension
to Use Existing Label Stock after the
Trans Fat Labeling Effective Date of
January 1, 2006’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (the PRA). Elsewhere in this
issue of the Federal Register, FDA is
publishing a notice announcing an
opportunity for public comment on this
collection of information. Since this
collection received emergency approval
that expires on January 1, 2006, FDA is
following the normal PRA clearance
procedures by issuing that notice.
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: In the
Federal Register of September 1, 2005
(70 FR 52108), the agency announced
that the proposed information collection
VerDate Aug<31>2005
18:49 Nov 21, 2005
Jkt 208001
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Commission on
Childhood Vaccines (ACCV).
Date and Time: December 12, 2005, 9
a.m.—5 p.m., EST.
Place: Audio Conference Call and
Parklawn Building, Conference Rooms G & H,
5600 Fishers Lane, Rockville, MD 20857.
The ACCV will meet on Monday,
December 12, from 9 a.m. to 5 p.m. The
public can join the meeting in person at the
address listed above or by audio conference
call by dialing 1–800–369–6048 on December
12 and providing the following information:
Leader’s Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the
December meeting will include, but are not
limited to: A summary of the U.S. Court of
Federal Claims’ 18th Judicial Conference; a
report from the ACCV Workgroup looking at
proposed guidelines for future changes to the
Vaccine Injury Table; and updates from the
Division of Vaccine Injury Compensation
(DVIC), Department of Justice, National
Vaccine Program Office, Immunization Safety
Office (Centers for Disease Control and
Prevention), National Institute of Allergy and
Infectious Diseases (National Institutes of
Health), and Center for Biologics and
Evaluation Research (Food and Drug
Administration). Agenda items are subject to
change as priorities dictate.
Public Comments: Persons interested in
providing an oral presentation should submit
a written request, along with a copy of their
presentation to: Ms. Cheryl Lee, Principal
Staff Liaison, DVIC, Healthcare Systems
Bureau (HSB), Health Resources and Services
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Publication of OIG Special Advisory
Bulletin on Patient Assistance
Programs for Medicare Part D
Enrollees
Office of Inspector General
(OIG), HHS.
ACTION: Notice.
AGENCY:
SUMMARY: OIG periodically develops
and issues guidance, including Special
Advisory Bulletins, to alert and inform
the health care industry about potential
problems or areas of special interest.
This Federal Register notice sets forth
the recently issued OIG Special
Advisory Bulletin addressing patient
assistance programs for Medicare Part D
enrollees.
FOR FURTHER INFORMATION CONTACT:
Darlene M. Hampton, Office of Counsel
to the Inspector General, (202) 619–
0335.
SUPPLEMENTARY INFORMATION:
Special Advisory Bulletin: Patient
Assistance Programs for Medicare Part
D Enrollees (November 2005)
I. Introduction
Patient assistance programs (PAPs)
have long provided important safety net
assistance to patients of limited means
E:\FR\FM\22NON1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 224 (Tuesday, November 22, 2005)]
[Notices]
[Pages 70621-70623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23040]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 (https://
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Written requests 28 1 28 5 140
to FDA in year
two
----------------------------------------------------------------------------------------------------------------
Onetime burden hours for years one and two 420
----------------------------------------------------------------------------------------------------------------
\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
