Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 75555-75557 [E6-21375]
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Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices
FDA will use the information from the
proposed experimental study to
evaluate regulatory policy options. The
agency often lacks empirical data about
how consumers understand and
respond to statements they might see in
product labeling. The information
gathered from this proposed
experimental study will be used by the
agency to assess likely consumer
responses to various disclosure
requirements for nutrient content
claims.
In the Federal Register of February 6,
2006 (71 FR 6076), FDA published a 60–
day notice requesting public comment
on the information collection that will
take place as part of the experimental
study. FDA received one letter in
response to the notice, containing
multiple comments.
(Comment 1) One comment stated
that the organization concurs with the
objectives of the study and believes the
information from this study will be
useful to FDA in developing labeling
policy to assist consumers with
interpretation of trans fat claims in food
labeling. Another comment suggested
that FDA change the labels used to
describe the three fatty acid profiles in
the study (‘‘good profile,’’ ‘‘medium
profile,’’ and ‘‘poor profile’’) because
these descriptors were seen as overly
negative. The comment recommended
alternative language (‘‘low profile,’’
‘‘medium profile’’ and ‘‘high profile’’) as
a way to ensure that the products are
not characterized as ‘‘good foods’’ or
‘‘bad foods.’’
(Response) This suggestion has been
implemented. The terminology
suggested in the comment adequately
conveys the intended profile
differences.
(Comment 2) One comment critiqued
the draft Full Information treatment
language. The comment criticized the
one-page summary because it : (1) Did
not identify calories in the discussion of
fat as a major source of energy and (2)
did not relate the calorie contribution of
fat to that of carbohydrates and protein.
The comment also criticized the
information about sources of trans fat
because it omitted mention of natural
sources of trans fat in the diet, which
the comment suggested would help
ensure factually correct and balanced
information about sources of trans in
the diet. The comment questioned the
value of stating that trans fat extends
shelflife and has desirable taste
characteristics since many saturated fat
sources are relatively shelf stable and
have desirable taste characteristics.
(Response) FDA agrees and has
revised the Full Information treatment
to incorporate these concerns. Calories
and other sources of energy are now
mentioned in the introductory passage.
Natural sources of trans fat are now
mentioned and the similarity between
trans fat and saturated fat in terms of
shelflife and taste are now addressed.
The revised draft will be included in the
study pretest and further revisions will
be made if FDA determines they are
needed based upon pretest results.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Pretest
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
40
1
40
.25
10
2,880
Study
1
2,880
.25
720
Total
730
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21317 Filed 12–14–06; 8:45 am]
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
BILLING CODE 4160–01–S
DATES:
Fax written comments on the
collection of information by January 16,
2007.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2006N–0197]
mstockstill on PROD1PC61 with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Food Facilities Under the Public Health
Security and Bioterrorism
Preparedness and Response Act of
2002
AGENCY:
Food and Drug Administration,
HHS.
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: FDA Desk Officer, FAX:
202–395–6974.
ADDRESSES:
Food and Drug Administration
ACTION:
Total Hours
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
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15:47 Dec 14, 2006
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Registration of Food Facilities Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002—21 CFR 1.230
through 1.235 (OMB Control Number
0910–0502)—Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) added section 415 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 350d), which requires
domestic and foreign facilities that
manufacture, process, pack, or hold
food for human or animal consumption
in the United States to register with
FDA. Sections 1.230 through 1.235 (21
CFR 1.230 through 1.235) set forth the
procedures for registration of food
facilities. Information provided to FDA
under these regulations will help the
agency to notify quickly the facilities
that might be affected by a deliberate or
accidental contamination of the food
supply.
Description of respondents: The
respondents to this information
collection include owners, operators, or
E:\FR\FM\15DEN1.SGM
15DEN1
75556
Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices
agents in charge of domestic or foreign
facilities that manufacture/process,
pack, or hold food for human or animal
consumption in the United States.
Domestic facilities are required to
register whether or not food from the
facility enters interstate commerce.
Foreign facilities that manufacture/
process, pack, or hold food also are
required to register unless food from
that facility undergoes further
processing (including packaging) by
another foreign facility before the food
is exported to the United States.
However, if the subsequent foreign
facility performs only a minimal
activity, such as putting on a label, both
facilities are required to register.
FDA’s regulations require that each
facility that manufactures, processes,
packs, or holds food for human or
animal consumption in the United
States register with FDA using Form
FDA 3537 (§ 1.231). The term ‘‘Form
FDA 3537’’ refers to both the paper
version of the form and the electronic
system known as the Food Facility
Registration Module, which is available
at https://www.access.fda.gov. The
agency strongly encourages electronic
registration because it is faster and more
convenient. The system the agency has
developed can accept electronic
registrations from anywhere in the
world 24 hours a day, 7 days a week,
365 days a year. A registering facility
will receive confirmation of electronic
registration and its registration number
instantaneously once all the required
fields on the registration screen are
filled in. However, paper registrations
will be accepted. Form FDA 3537 is
available for download for registration
by mail, fax, or CD–ROM. Registration
by mail may take several weeks to
several months, depending on the speed
of the mail system and the number of
paper registrations that FDA will have
to enter manually.
Information FDA requires on the
registration form includes the name and
full address of the facility; emergency
contact information; all trade names the
facility uses; applicable food product
categories identified in § 170.3 (21 CFR
170.3), unless ‘‘most/all’’ human food
categories ‘‘or none of the above
mandatory categories’’ is selected as a
response; and a certification statement
that includes the name of the individual
authorized to submit the registration
form. Additionally, facilities are
encouraged to submit their preferred
mailing address; type of activity
conducted at the facility; food categories
not included under § 170.3, but which
are helpful to FDA for responding to an
incident; type of storage, if the facility
is primarily a holding facility; and
approximate dates of operation if the
facility’s business is seasonal.
In addition to registering, a facility is
required to submit timely updates
within 60 days of a change to any
required information on its registration
form, using Form FDA 3537 (§ 1.234),
and to cancel its registration when the
facility ceases to operate or is sold to
new owners or ceases to manufacture/
process, pack, or hold food for
consumption in the United States, using
Form FDA 3537a (§ 1.235).
In the Federal Register of June 2, 2006
(71 FR 32103), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
We received no comments.
FDA estimates the burden of
complying with the information
collection provisions of the agency’s
regulations for food facility registration
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
FDA
Form No.
21 CFR Section
No. of
Respondents
Annual Frequency
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
New Facilities
Domestic
1.230 through 1.233
FDA 35372
13,650
1
13,650
2.5
34,125
FDA 3537
29,200
1
29,200
8.5
248,200
Foreign
1.230 through 1.233
New Facility Registration Subtotal
282,325
Previously Registered Facilities-Updates (Form 3537) and Cancellations (Form 3537a)
1.234
FDA 3537
92,850
1
92,850
1
92,850
1.235
FDA 3537a
1,300
1
1,300
1
1,300
Updates or Cancellations to Existing Registration Subtotal
94,150
Total Hours Annually
376,475
1 There
mstockstill on PROD1PC61 with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The term ‘‘Form FDA 3537’’ refers to both the paper version of the form and the electronic system known as the Food Facility Registration
Module, which is available at https://www.access.fda.gov.
This estimate is based on FDA’s
experience and the average number of
new facility registrations, updates and
cancellations received in the past 3
years. FDA received 82,485 new
domestic facility registrations during
2003; 32,099 during 2004; and 13,652
during 2005. Based on this experience,
VerDate Aug<31>2005
15:47 Dec 14, 2006
Jkt 211001
FDA estimates the annual number of
new domestic facility registrations will
be 13,650. FDA estimates that listing the
information required by the
Bioterrorism Act and presenting it in a
format that will meet the agency’s
registration regulations will require a
burden of approximately 2.5 hours per
PO 00000
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Fmt 4703
Sfmt 4703
average domestic facility registration.
The average domestic facility burden
hour estimate of 2.5 hours takes into
account that some respondents
completing the registration may not
have readily available Internet access.
Thus, the total annual burden for new
domestic facility registrations is
E:\FR\FM\15DEN1.SGM
15DEN1
Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices
mstockstill on PROD1PC61 with NOTICES
estimated to be 34,125 hours (13,650 x
2.5 hours).
FDA received 89,990 new foreign
facility registrations during 2003; 49,574
during 2004; and 29,193 during 2005.
Based on this experience, FDA estimates
the annual number of new foreign
facility registrations will be 29,200. FDA
estimates that listing the information
required by the Bioterrorism Act and
presenting it in a format that will meet
the agency’s registration regulations will
require a burden of approximately 8.5
hours per average foreign facility
registration. The average foreign facility
burden hour estimate of 8.5 hours
includes an estimate of the additional
burden on a foreign facility to obtain a
U.S. agent, and takes into account that
for some foreign facilities the
respondent completing the registration
may not be fluent in English and/or not
have readily available Internet access.
Thus, the total annual burden for new
foreign facility registrations is estimated
to be 248,200 hours (29,200 x 8.5 hours).
FDA received 131,354 updates to
facility registrations during 2003;
137,384 during 2004; and 92,835 during
2005. Based on this experience, FDA
estimates that it will receive 92,850
updates annually. FDA also estimates
that updating a registration will, on
average, require a burden of
approximately 1 hour, taking into
account fluency in English and Internet
access. Thus, the total annual burden for
updating all registrations is estimated to
be 92,850 hours.
FDA received 12,556 cancellations of
facility registrations during 2003; 7,467
during 2004; and 1,280 during 2005.
Based on this experience, FDA estimates
the annual number of cancellations will
be 1,300. FDA also estimates that
cancelling a registration will, on
average, require a burden of
approximately 1 hour, taking into
account fluency in English and Internet
access. Thus, the total annual burden for
cancelling registrations is estimated to
be 1,300 hours.
In cases where a regulation
implements a statutory information
collection requirement, only the
additional burden attributable to the
regulation, if any, has been included in
FDA’s burden estimate.
Dated: December 11, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21375 Filed 12–14–06; 8:45 am]
BILLING CODE 4160–01–S
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15:47 Dec 14, 2006
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0476]
Drug Products Containing Quinine;
Enforcement Action Dates
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
intention to take enforcement action
against unapproved drug products
containing quinine (including quinine
sulfate and any other salt of quinine)
and persons who cause the manufacture
of such products or their shipment in
interstate commerce. Drug products
containing quinine, quinine sulfate, and
any other salt of quinine are new drugs
that require approved applications. One
firm has an approved application to
market a drug product containing
quinine sulfate to treat malaria; this
product has been designated an orphan
drug product. Other manufacturers who
wish to market a drug product
containing quinine, quinine sulfate, or
any other salt of quinine must obtain
FDA approval of a new drug application
(NDA) or an abbreviated new drug
application (ANDA); consideration of
any such applications will be subject to
the rights of the current NDA holder
under the Orphan Drug Act.
DATES: This notice is effective December
15, 2006.
For marketed, unapproved drug
products containing quinine, quinine
sulfate, or any salt of quinine that have
a National Drug Code (NDC) number
that is listed with FDA on the effective
date of this notice (i.e., ‘‘currently
marketed products’’), however, the
agency intends to exercise its
enforcement discretion to permit
products marketed with those NDC
numbers a brief period of continued
marketing after December 15, 2006 as
follows. Any firm manufacturing such
an unapproved product may not
manufacture that product on or after
February 13, 2007. Any firm distributing
such an unapproved product may not
ship the product in interstate commerce
on or after June 13, 2007. Unapproved
drug products containing quinine,
quinine sulfate, or any salt of quinine
that are not currently marketed products
on the effective date of this notice must,
as of the effective date of this notice,
have approved applications prior to
their shipment in interstate commerce.
Submission of an application does not
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
75557
excuse timely compliance with this
notice.
All communications in
response to this notice should be
identified with Docket No. 2006N–0476
and directed to the appropriate office
listed as follows:
Regarding applications under section
505(b) of the Federal Food, Drug,
and Cosmetic Act (the act) (21
U.S.C. 355(b)): Division of Special
Pathogen and Transplant Products,
Office of New Drugs, Center for
Drug Evaluation and Research,
Food and Drug Administration,
10903 New Hampshire Ave., Bldg.
22, Silver Spring, MD 20993–0002.
Regarding applications under section
505(j) of the act: Office of Generic
Drugs, Center for Drug Evaluation
and Research (HFD–600), Food and
Drug Administration, 7520 Standish
Pl., Rockville, MD 20855.
All other communications: John Loh,
Center for Drug Evaluation and
Research (HFD–310), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: John
Loh, Center for Drug Evaluation and
Research (HFD–310), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–8965, email: john.loh@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
Quinine is the chief alkaloid of
cinchona, the bark of the cinchona tree
indigenous to parts of South America.
Recorded medical use of cinchona dates
back to the 17th century. Quinine was
first isolated from cinchona in 1820.
Quinine (the term ‘‘quinine’’ as used in
this notice refers to quinine, quinine
sulfate, and other quinine salts) has
been used to treat malaria since the 19th
century. It was used extensively for
mass prophylaxis in malaria control
programs in the early 20th century. As
more predictable and effective synthetic
antimalarial drugs began to be
developed in the 1930s, the use of
quinine to treat and/or prevent malaria
declined. However, with the increasing
resistance of the malaria parasite to
some of these synthetic malarial
treatments, quinine is again emerging as
an important treatment for malaria.
Quinine also has been used for the
treatment and/or prevention of
nocturnal leg muscle cramps, similar
conditions such as a restless leg
syndrome, and, very rarely, a number of
other conditions, including Babesiosis
(another parasitic infection) and certain
myotonic disorders. The predominant
E:\FR\FM\15DEN1.SGM
15DEN1
]]>Agencies
[Federal Register Volume 71, Number 241 (Friday, December 15, 2006)]
[Notices]
[Pages 75555-75557]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21375]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0197]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration of Food
Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 January
16, 2007.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (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.
Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.230
through 1.235 (OMB Control Number 0910-0502)--Extension
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) added section 415 of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350d), which
requires domestic and foreign facilities that manufacture, process,
pack, or hold food for human or animal consumption in the United States
to register with FDA. Sections 1.230 through 1.235 (21 CFR 1.230
through 1.235) set forth the procedures for registration of food
facilities. Information provided to FDA under these regulations will
help the agency to notify quickly the facilities that might be affected
by a deliberate or accidental contamination of the food supply.
Description of respondents: The respondents to this information
collection include owners, operators, or
[[Page 75556]]
agents in charge of domestic or foreign facilities that manufacture/
process, pack, or hold food for human or animal consumption in the
United States. Domestic facilities are required to register whether or
not food from the facility enters interstate commerce. Foreign
facilities that manufacture/process, pack, or hold food also are
required to register unless food from that facility undergoes further
processing (including packaging) by another foreign facility before the
food is exported to the United States. However, if the subsequent
foreign facility performs only a minimal activity, such as putting on a
label, both facilities are required to register.
FDA's regulations require that each facility that manufactures,
processes, packs, or holds food for human or animal consumption in the
United States register with FDA using Form FDA 3537 (Sec. 1.231). The
term ``Form FDA 3537'' refers to both the paper version of the form and
the electronic system known as the Food Facility Registration Module,
which is available at https://www.access.fda.gov. The agency strongly
encourages electronic registration because it is faster and more
convenient. The system the agency has developed can accept electronic
registrations from anywhere in the world 24 hours a day, 7 days a week,
365 days a year. A registering facility will receive confirmation of
electronic registration and its registration number instantaneously
once all the required fields on the registration screen are filled in.
However, paper registrations will be accepted. Form FDA 3537 is
available for download for registration by mail, fax, or CD-ROM.
Registration by mail may take several weeks to several months,
depending on the speed of the mail system and the number of paper
registrations that FDA will have to enter manually.
Information FDA requires on the registration form includes the name
and full address of the facility; emergency contact information; all
trade names the facility uses; applicable food product categories
identified in Sec. 170.3 (21 CFR 170.3), unless ``most/all'' human
food categories ``or none of the above mandatory categories'' is
selected as a response; and a certification statement that includes the
name of the individual authorized to submit the registration form.
Additionally, facilities are encouraged to submit their preferred
mailing address; type of activity conducted at the facility; food
categories not included under Sec. 170.3, but which are helpful to FDA
for responding to an incident; type of storage, if the facility is
primarily a holding facility; and approximate dates of operation if the
facility's business is seasonal.
In addition to registering, a facility is required to submit timely
updates within 60 days of a change to any required information on its
registration form, using Form FDA 3537 (Sec. 1.234), and to cancel its
registration when the facility ceases to operate or is sold to new
owners or ceases to manufacture/process, pack, or hold food for
consumption in the United States, using Form FDA 3537a (Sec. 1.235).
In the Federal Register of June 2, 2006 (71 FR 32103), FDA
published a 60-day notice requesting public comment on the information
collection provisions. We received no comments.
FDA estimates the burden of complying with the information
collection provisions of the agency's regulations for food facility
registration as follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
FDA Form No. of Annual Frequency Total Annual Hours per
21 CFR Section No. Respondents per Respondent Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
New Facilities
----------------------------------------------------------------------------------------------------------------
Domestic
----------------------------------------------------------------------------------------------------------------
1.230 through FDA 3537\2\ 13,650 1 13,650 2.5 34,125
1.233
----------------------------------------------------------------------------------------------------------------
Foreign
----------------------------------------------------------------------------------------------------------------
1.230 through FDA 3537 29,200 1 29,200 8.5 248,200
1.233
----------------------------------------------------------------------------------------------------------------
New Facility Registration Subtotal 282,325
����������������������������������������������������������������������������������������������������������������
Previously Registered Facilities-Updates (Form 3537) and Cancellations (Form 3537a)
----------------------------------------------------------------------------------------------------------------
1.234 FDA 3537 92,850 1 92,850 1 92,850
----------------------------------------------------------------------------------------------------------------
1.235 FDA 3537a 1,300 1 1,300 1 1,300
----------------------------------------------------------------------------------------------------------------
Updates or Cancellations to Existing Registration Subtotal 94,150
����������������������������������������������������������������������������������������������������������������
Total Hours Annually 376,475
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The term ``Form FDA 3537'' refers to both the paper version of the form and the electronic system known as
the Food Facility Registration Module, which is available at https://www.access.fda.gov.
This estimate is based on FDA's experience and the average number
of new facility registrations, updates and cancellations received in
the past 3 years. FDA received 82,485 new domestic facility
registrations during 2003; 32,099 during 2004; and 13,652 during 2005.
Based on this experience, FDA estimates the annual number of new
domestic facility registrations will be 13,650. FDA estimates that
listing the information required by the Bioterrorism Act and presenting
it in a format that will meet the agency's registration regulations
will require a burden of approximately 2.5 hours per average domestic
facility registration. The average domestic facility burden hour
estimate of 2.5 hours takes into account that some respondents
completing the registration may not have readily available Internet
access. Thus, the total annual burden for new domestic facility
registrations is
[[Page 75557]]
estimated to be 34,125 hours (13,650 x 2.5 hours).
FDA received 89,990 new foreign facility registrations during 2003;
49,574 during 2004; and 29,193 during 2005. Based on this experience,
FDA estimates the annual number of new foreign facility registrations
will be 29,200. FDA estimates that listing the information required by
the Bioterrorism Act and presenting it in a format that will meet the
agency's registration regulations will require a burden of
approximately 8.5 hours per average foreign facility registration. The
average foreign facility burden hour estimate of 8.5 hours includes an
estimate of the additional burden on a foreign facility to obtain a
U.S. agent, and takes into account that for some foreign facilities the
respondent completing the registration may not be fluent in English
and/or not have readily available Internet access. Thus, the total
annual burden for new foreign facility registrations is estimated to be
248,200 hours (29,200 x 8.5 hours).
FDA received 131,354 updates to facility registrations during 2003;
137,384 during 2004; and 92,835 during 2005. Based on this experience,
FDA estimates that it will receive 92,850 updates annually. FDA also
estimates that updating a registration will, on average, require a
burden of approximately 1 hour, taking into account fluency in English
and Internet access. Thus, the total annual burden for updating all
registrations is estimated to be 92,850 hours.
FDA received 12,556 cancellations of facility registrations during
2003; 7,467 during 2004; and 1,280 during 2005. Based on this
experience, FDA estimates the annual number of cancellations will be
1,300. FDA also estimates that cancelling a registration will, on
average, require a burden of approximately 1 hour, taking into account
fluency in English and Internet access. Thus, the total annual burden
for cancelling registrations is estimated to be 1,300 hours.
In cases where a regulation implements a statutory information
collection requirement, only the additional burden attributable to the
regulation, if any, has been included in FDA's burden estimate.
Dated: December 11, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21375 Filed 12-14-06; 8:45 am]
BILLING CODE 4160-01-S
