Agency Emergency Processing Under Office of Management and Budget Review; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007, 25750-25752 [E8-10194]
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Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices
Modernization Act of 1997, provides
that any person may market a food
product whose label bears a nutrient
content claim or a health claim that is
based on an authoritative statement of a
scientific body of the U.S. Government
or the National Academy of Sciences
(NAS). Under this section of the act, a
person that intends to use such a claim
must submit a notification of its
intention to use the claim 120 days
before it begins marketing the product
bearing the claim. In the Federal
Register of June 11, 1998 (63 FR 32102),
FDA announced the availability of a
guidance entitled ‘‘Guidance for
Industry: Notification of a Health Claim
or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body.’’ The guidance provides the
agency’s interpretation of terms central
to the submission of a notification and
the agency’s views on the information
that should be included in the
notification. The agency believes that
the guidance will enable persons to
meet the criteria for notifications that
are established in section 403(r)(2)(G)
and (r)(3)(C) of the act. In addition to the
information specifically required by the
act to be in such notifications, the
guidance states that the notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. FDA intends
to review the notifications the agency
receives to ensure that they comply with
the criteria established by the act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.— ESTIMATED ANNUAL REPORTING BURDEN1
Annual
Frequency per
Response
No. of
Respondents
Section of the Act/Basis of Burden
Total Annual
Responses
Hours Per
Response
Total Hours
403(r)(2)(G) (nutrient content claims)
1
1
1
250
250
403(r)(2)(C) (health claims)
2
1
2
450
900
Guidance for notifications
3
1
3
1
3
Total
sroberts on PROD1PC70 with NOTICES
1 There
1,153
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA’s
experience with health claims, nutrient
content claims, and other similar
notification procedures that fall under
the agency’s jurisdiction. FDA estimates
that it will receive one nutrient content
claim notification and two health claim
notifications per year.
Section 403(r)(2)(G) and 403(r)(3)(C)
of the act requires that the notification
include the exact words of the claim, a
copy of the authoritative statement, a
concise description of the basis upon
which such person relied for
determining that this is an authoritative
statement as outlined in the act, and a
balanced representation of the scientific
literature relating to the relationship
between a nutrient and a disease or
health-related condition to which a
health claim refers or to the nutrient
level to which the nutrient content
claim refers. This balanced
representation of the scientific literature
is expected to include a bibliography of
the scientific literature on the topic of
the claim and a brief, balanced account
or analysis of how this literature either
supports or fails to support the
authoritative statement.
Since the claims are based on
authoritative statements of a scientific
body of the Federal government or NAS,
FDA believes that the information that
is required by the act to be submitted
with a notification will be readily
available to a respondent. However, the
respondent will have to collect and
assemble that information. Based on
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communications with firms that have
submitted notifications, FDA estimates
that it will take a respondent 250 hours
to collect and assemble the information
required by the statute for nutrient
content claim notifications and 450
hours to collect and assemble the
information required by the statute for
health claim notifications.
Under the guidance, notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. The
guidance applies to both nutrient
content claim and health claim
notifications. FDA has determined that
this information should be readily
available to a respondent and, thus, the
agency estimates that it will take a
respondent 1 hour to incorporate the
information into the notification.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: May 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–10180 Filed 5–6–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0269]
Agency Emergency Processing Under
Office of Management and Budget
Review; Implementation of Sections
222, 223, and 224 of the Food and Drug
Administration Amendments Act of
2007
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 emergency processing under
the Paperwork Reduction Act of 1995
(the PRA). The proposed collection of
information concerns the requirement
established by the Food and Drug
Administration Amendments Act of
2007 (FDAAA), that device
establishments must submit registration
and listing information by electronic
means using FDA Form 3673, unless the
Secretary of Health and Human Services
(the Secretary) grants them a waiver
from the electronic submission
requirement.
DATES: Fax written comments on the
collection of information by June 6,
2008.
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25751
Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices
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, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–NEW and title
‘‘Implementation of Sections 222, 223,
and 224 of the Food and Drug
Administration Amendments Act of
2007; (21 U.S.C. 360); Emergency
Request.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: FDA is
requesting 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)). Title
II of FDAAA (Public Law 110–85),
enacted September 27, 2007, amends
section 510 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360) to require all domestic and foreign
device establishments to submit
registration and device listing
information to FDA by electronic
means, and specifies the timeframes
when establishments are required to
submit such information. These new
registration and listing requirements
were in effect on October 1, 2007. The
proposed collection of information
concerns the information that owners/
operators of device establishments must
submit electronically in order to register
their establishments and list their
devices using FDA Form No. 3673. In
addition, owners/operators seeking a
waiver from the electronic submission
ADDRESSES:
requirements will need to submit a
written request for a waiver to FDA with
a complete explanation as to why their
registration and listing information
cannot be submitted electronically. See
sections 222, 223, and 224 of FDAAA.
Thus, FDA is requesting emergency
processing of this new collection of
information for electronic registration
and listing, and information relating to
requests for waivers.
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.
Implementation of Sections 222, 223,
and 224 of the Food and Drug
Administration Amendments Act of
2007; (21 U.S.C. 360); Emergency
Request
Sections 222, 223, and 224 of FDAAA,
which were in effect on October 1, 2007,
require that device establishment
registrations and listings under section
510 of the FD&C Act (including the
submission of updated information) be
submitted to the Secretary by electronic
means, unless the Secretary grants a
request for waiver of the requirement
because the use of electronic means is
not reasonable for the person requesting
the waiver. FDA expects that 20,000 to
30,000 device establishments will need
to register electronically between now
and December 31, 2008. Section 224 of
FDAAA requires that these
establishments also must have an
opportunity request waivers. Thus,
emergency approval of this request is
necessary to implement these provisions
of the statute.
Section 222 of FDAAA amends
section 510(b) of the FD&C Act to
require domestic establishments to
register annually during the period
beginning October 1 and ending
December 31 of each year. Section 222
of FDAAA also amends section 510(i)(1)
of the FD&C Act to require foreign
establishments to immediately register
upon first engaging in one of the
covered device activities described
under the statute, and they must also
register annually during the period
beginning on October 1 and ending on
December 31 of each year. In addition,
section 223 of FDAAA amends section
510(j)(2) of the FD&C Act to require
establishments to list their devices
annually with FDA during the period
beginning on October 1 and ending on
December 31 of each year.
Under FDAAA, device establishment
owners/operators are required to keep
their registration and device listing
information up-to-date using the
agency’s new electronic system.
Owners/operators of new device
establishments must use the electronic
system to create new accounts, new
registration records, and new device
listings. Section 224 of FDAAA amends
section 510(p) of the FD&C Act by
allowing a person affected to request a
waiver from the requirement to register
electronically when the ‘‘use of
electronic means’’ is not reasonable for
the person.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of
the 2007
Amendments
FDA Form No.
No.
of Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours
per Response
Total Hours
3673
2,600
1
2,704
0.5
1,352
2232
3673
24,382
1
24,382
0.25
6,095
2242
29,370
1
29,370
0.75
22,028
2243
sroberts on PROD1PC70 with NOTICES
2222
2,600
1
2,600
0.5
1,300
224 (waiver request)2
20
1
20
1
20
224 (waiver request)3
1
1
1
1
1
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25752
Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Section of
the 2007
Amendments
FDA Form No.
No.
of Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours
per Response
Total Hours
Total Hours
30,796
1 There
sroberts on PROD1PC70 with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 One time burden.
3 Annual increase in burden.
The estimates in table 1 of this
document are based on FDA’s
experience, data from the device
registration and listing database, and
our estimates of the time needed to
complete the previously required forms.
We estimate that the time needed to
enter registration and listing
information electronically using FDA
Form 3673 will not differ significantly
from the time needed to fill in the paper
forms (FDA Forms 2891, 2891a, and
2892) that previously were used for this
purpose because the information
required is essentially identical.
In addition, under section 224 of
FDAAA, device establishments owner/
operators for whom registering and
listing by electronic means is not
reasonable may request a waiver from
the Secretary. Because a device
establishment’s owner/operator required
to register and list would only need to
have access to a computer, Internet, and
an e-mail address for registration and
list by electronic means, the agency did
not anticipate the receipt of a large
number of requests for waiver. For the
first few months of operation of the
web-based system, i.e., October through
December 2007, FDA received fewer
than 10 requests for waivers from the
requirement to submit registration and
listing information electronically. As
data for more than 16,000
establishments have been received
electronically for the same period, these
requests amount to less than 1 percent
of the total number of establishments
that have responded.
Based on information taken from our
databases, FDA estimates that there are
29,370 owner/operators who
collectively register a total of 33,490
device establishments. The number of
respondents listed for section 224 of
FDAAA in the burden table is 29,370,
which corresponds to the number of
owner/operators who annually register
one or more establishments. In addition,
FDA estimates that 4,988 owner/
operators are initial importers who must
register their establishments but who,
under FDA’s existing regulations, are
not required to list their devices unless
they initiate or develop the
specifications for the devices or
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repackage or relabel the devices. The
number of respondents included in the
burden table for section 223 of FDAAA
is 24,382, which corresponds to the
number of owner/operators who list one
or more devices annually (29,370 - 4,988
= 24,382).
To calculate the burden estimate for
waiver requests under section 224 of
FDAAA, we assume as stated previously
that less than one tenth of one percent
of the 33,490 total device establishments
would request waivers from FDA. This
means the total number of waiver
requests would probably not exceed 20
requests (33,490 x 0.0006). We also
estimate that the one-time burden on
these establishments would be an hour
of time for a mid-level manager to draft,
approve, and mail a letter. In addition,
FDA estimates the total number of
establishments will increase by 2,600
new establishments each year. Of the
2,600 new registrants each year, we
assume that less than one percent (i.e.,
1) of these will also request waivers
each year. The total, therefore, is 21
waiver requests, which could increase
by only 1 additional request each year.
Dated: May 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–10194 Filed 5–6–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0228] (formerly
Docket No. 00D–1401)
Guidance for Industry and Food and
Drug Administration Staff;
Administrative Procedures for CLIA
Categorization; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Administrative Procedures for CLIA
PO 00000
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Categorization.’’ The guidance describes
FDA’s current practices concerning the
administrative aspects of categorizing
commercially available in vitro
diagnostic tests under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA). The guidance discusses
what manufacturers should submit to
help expedite CLIA categorization by
FDA.
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Administrative Procedures for
CLIA Categorization’’ to the Division of
Small Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
assist the office in processing your
request, or fax your request to 240–276–
3151. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Carol Benson, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 2098 Gaither
Rd., Rockville, MD 20850, 240–276–
0491, ext. 117.
SUPPLEMENTARY INFORMATION:
I. Background
On February 28, 1992, the Department
of Health and Human Services
published the final laboratory standards
regulations (57 FR 7002) implementing
CLIA (42 U.S.C. 263a). The
implementing regulations are codified at
42 CFR part 493. CLIA regulates
laboratory testing and requires that
clinical laboratories obtain a certificate
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]]>Agencies
[Federal Register Volume 73, Number 89 (Wednesday, May 7, 2008)]
[Notices]
[Pages 25750-25752]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10194]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0269]
Agency Emergency Processing Under Office of Management and Budget
Review; Implementation of Sections 222, 223, and 224 of the Food and
Drug Administration Amendments Act of 2007
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 emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of
information concerns the requirement established by the Food and Drug
Administration Amendments Act of 2007 (FDAAA), that device
establishments must submit registration and listing information by
electronic means using FDA Form 3673, unless the Secretary of Health
and Human Services (the Secretary) grants them a waiver from the
electronic submission requirement.
DATES: Fax written comments on the collection of information by June
6, 2008.
[[Page 25751]]
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, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-NEW and title
``Implementation of Sections 222, 223, and 224 of the Food and Drug
Administration Amendments Act of 2007; (21 U.S.C. 360); Emergency
Request.'' Also include the FDA docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: FDA is requesting 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)). Title II of FDAAA (Public
Law 110-85), enacted September 27, 2007, amends section 510 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) to
require all domestic and foreign device establishments to submit
registration and device listing information to FDA by electronic means,
and specifies the timeframes when establishments are required to submit
such information. These new registration and listing requirements were
in effect on October 1, 2007. The proposed collection of information
concerns the information that owners/operators of device establishments
must submit electronically in order to register their establishments
and list their devices using FDA Form No. 3673. In addition, owners/
operators seeking a waiver from the electronic submission requirements
will need to submit a written request for a waiver to FDA with a
complete explanation as to why their registration and listing
information cannot be submitted electronically. See sections 222, 223,
and 224 of FDAAA. Thus, FDA is requesting emergency processing of this
new collection of information for electronic registration and listing,
and information relating to requests for waivers.
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.
Implementation of Sections 222, 223, and 224 of the Food and Drug
Administration Amendments Act of 2007; (21 U.S.C. 360); Emergency
Request
Sections 222, 223, and 224 of FDAAA, which were in effect on
October 1, 2007, require that device establishment registrations and
listings under section 510 of the FD&C Act (including the submission of
updated information) be submitted to the Secretary by electronic means,
unless the Secretary grants a request for waiver of the requirement
because the use of electronic means is not reasonable for the person
requesting the waiver. FDA expects that 20,000 to 30,000 device
establishments will need to register electronically between now and
December 31, 2008. Section 224 of FDAAA requires that these
establishments also must have an opportunity request waivers. Thus,
emergency approval of this request is necessary to implement these
provisions of the statute.
Section 222 of FDAAA amends section 510(b) of the FD&C Act to
require domestic establishments to register annually during the period
beginning October 1 and ending December 31 of each year. Section 222 of
FDAAA also amends section 510(i)(1) of the FD&C Act to require foreign
establishments to immediately register upon first engaging in one of
the covered device activities described under the statute, and they
must also register annually during the period beginning on October 1
and ending on December 31 of each year. In addition, section 223 of
FDAAA amends section 510(j)(2) of the FD&C Act to require
establishments to list their devices annually with FDA during the
period beginning on October 1 and ending on December 31 of each year.
Under FDAAA, device establishment owners/operators are required to
keep their registration and device listing information up-to-date using
the agency's new electronic system. Owners/operators of new device
establishments must use the electronic system to create new accounts,
new registration records, and new device listings. Section 224 of FDAAA
amends section 510(p) of the FD&C Act by allowing a person affected to
request a waiver from the requirement to register electronically when
the ``use of electronic means'' is not reasonable for the person.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Section of the 2007 Amendments FDA Form No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
222\2\ 3673 2,600 1 2,704 0.5 1,352
--------------------------------------------------------------------------------------------------------------------------------------------------------
223\2\ 3673 24,382 1 24,382 0.25 6,095
--------------------------------------------------------------------------------------------------------------------------------------------------------
224\2\ ................. 29,370 1 29,370 0.75 22,028
--------------------------------------------------------------------------------------------------------------------------------------------------------
224\3\ ................. 2,600 1 2,600 0.5 1,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
224 (waiver request)\2\ ................. 20 1 20 1 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
224 (waiver request)\3\ ................. 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 25752]]
Total Hours 30,796
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ One time burden.
\3\ Annual increase in burden.
The estimates in table 1 of this document are based on FDA's
experience, data from the device registration and listing database, and
our estimates of the time needed to complete the previously required
forms. We estimate that the time needed to enter registration and
listing information electronically using FDA Form 3673 will not differ
significantly from the time needed to fill in the paper forms (FDA
Forms 2891, 2891a, and 2892) that previously were used for this purpose
because the information required is essentially identical.
In addition, under section 224 of FDAAA, device establishments
owner/operators for whom registering and listing by electronic means is
not reasonable may request a waiver from the Secretary. Because a
device establishment's owner/operator required to register and list
would only need to have access to a computer, Internet, and an e-mail
address for registration and list by electronic means, the agency did
not anticipate the receipt of a large number of requests for waiver.
For the first few months of operation of the web-based system, i.e.,
October through December 2007, FDA received fewer than 10 requests for
waivers from the requirement to submit registration and listing
information electronically. As data for more than 16,000 establishments
have been received electronically for the same period, these requests
amount to less than 1 percent of the total number of establishments
that have responded.
Based on information taken from our databases, FDA estimates that
there are 29,370 owner/operators who collectively register a total of
33,490 device establishments. The number of respondents listed for
section 224 of FDAAA in the burden table is 29,370, which corresponds
to the number of owner/operators who annually register one or more
establishments. In addition, FDA estimates that 4,988 owner/operators
are initial importers who must register their establishments but who,
under FDA's existing regulations, are not required to list their
devices unless they initiate or develop the specifications for the
devices or repackage or relabel the devices. The number of respondents
included in the burden table for section 223 of FDAAA is 24,382, which
corresponds to the number of owner/operators who list one or more
devices annually (29,370 - 4,988 = 24,382).
To calculate the burden estimate for waiver requests under section
224 of FDAAA, we assume as stated previously that less than one tenth
of one percent of the 33,490 total device establishments would request
waivers from FDA. This means the total number of waiver requests would
probably not exceed 20 requests (33,490 x 0.0006). We also estimate
that the one-time burden on these establishments would be an hour of
time for a mid-level manager to draft, approve, and mail a letter. In
addition, FDA estimates the total number of establishments will
increase by 2,600 new establishments each year. Of the 2,600 new
registrants each year, we assume that less than one percent (i.e., 1)
of these will also request waivers each year. The total, therefore, is
21 waiver requests, which could increase by only 1 additional request
each year.
Dated: May 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10194 Filed 5-6-08; 8:45 am]
BILLING CODE 4160-01-S
