Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations, 15753-15756 [E6-4507]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices
New NDAs (§ 314.50), ANDAs
(§ 314.94), and BLAs (§ 601.2): Based on
the number of submissions during 2005
under the approved collections of
information for §§ 314.50, 314.94, and
601.2, we estimate that approximately
75 NDA applicants, 160 ANDA
applicants, and 6 BLA applicants
(respondents) submit applications to us
annually. We estimate that these
applicants (respondents) submit
approximately 111 NDAs, 766 ANDAs,
and 21 BLAs each year that are subject
to the requirements of the final rule. As
explained in section V of the final rule,
we estimate that the hours per response,
i.e., the additional time necessary for
submission of the content of labeling in
electronic format for these applications,
will be less than 15 minutes.
Supplements to NDAs (§ 314.70),
ANDAs (§ 314.97), and BLAs
(§ 601.12(f)(1) and (f)(2)): Based on the
number of submissions during 2005
under the approved collections of
information for §§ 314.70, 314.97, and
§ 601.12(f)(1) and (f)(2), we estimate that
approximately 272 NDA applicants, 189
ANDA applicants, and 35 BLA
applicants (respondents) submit
supplements to approved applications
to us annually. We estimate that these
applicants (respondents) submit
approximately 1,839 NDA supplements,
3,208 ANDA supplements, and 82 BLA
supplements each year that are subject
to the requirements of the final rule. As
explained in section V of the final rule,
we estimate that the hours per response,
i.e., the additional time necessary for
submission of the content of labeling in
electronic format for these applications,
will be less than 15 minutes.
Annual Reports for NDAs (§ 314.81),
ANDAs (§ 314.98), and BLAs
(§ 601.12(f)(3)): Based on the number of
15753
submissions during 2005 under the
approved collections of information for
§§ 314.81, 314.98, and 601.12(f)(3), we
estimate that approximately 306 NDA
applicants, 333 ANDA applicants, and 4
BLA applicants (respondents) submit
annual reports to us annually. We
estimate that NDA applicants submit to
us approximately 2,617 annual reports,
ANDA applicants submit approximately
6,054 annual reports, and BLA
applicants submit approximately 16
annual reports each year that are subject
to the requirements of the final rule. As
explained in section V of the final rule,
we estimate that the hours per response,
i.e., the additional time necessary for
submission of the content of labeling in
electronic format for these submissions,
will be less than 15 minutes.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
New Applications
314.50
314.94
601.142
75
160
6
1.48
4.79
3.50
111
766
21
.25
.25
.25
27.75
191.50
5.25
272
189
35
6.76
16.98
2.34
1,839
3,208
82
.25
.25
.25
459.75
802
20.5
306
333
4
8.55
18.18
4
2,617
6,054
16
.25
.25
.25
654.25
1,513.50
4
Supplements
314.70
314.97
601.143
Annual Reports
314.81
314.98
601.144
Total
3,678.50
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
2Applications submitted under § 601.2.
3Supplements submitted under § 601.12(f)(1) and (f)(2).
4Annual reports submitted under § 601.12(f)(3).
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–4506 Filed 3–28–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
[Docket No. 2006N–0105]
Food and Drug Administration
hsrobinson on PROD1PC68 with NOTICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
VerDate Aug<31>2005
15:39 Mar 28, 2006
Jkt 208001
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
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 information collection contained in
FDA regulations entitled
‘‘Environmental Impact
Considerations.’’
E:\FR\FM\29MRN1.SGM
29MRN1
15754
Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices
Submit written or electronic
comments on the collection of
information by May 30, 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 20857. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
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.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(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
hsrobinson on PROD1PC68 with NOTICES
DATES:
VerDate Aug<31>2005
15:39 Mar 28, 2006
Jkt 208001
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Environmental Impact
Considerations—Part 25 (21 CFR Part
25) (OMB Control Number 0910–
0322)—Extension
FDA is requesting OMB approval for
the reporting requirements contained in
the FDA regulation ‘‘Environmental
Impact Considerations.’’
The National Environmental Policy
Act (NEPA) (42 U.S.C. 4321–4347),
states national environmental objectives
and imposes upon each Federal agency
the duty to consider the environmental
effects of its actions. Section 102(2)(C)
of NEPA requires the preparation of an
environmental impact statement (EIS)
for every major Federal action that will
significantly affect the quality of the
human environment.
The FDA NEPA regulations are at part
25. All applications or petitions
requesting agency action require the
submission of a claim for a categorical
exclusion or an environmental
assessment (EA). A categorical
exclusion applies to certain classes of
FDA-regulated actions that usually have
little or no potential to cause significant
environmental effects and are excluded
from the requirements to prepare an EA
or EIS. Section 25.15(a) and (d) specifies
the procedures for submitting to FDA a
claim for a categorical exclusion.
Extraordinary circumstances (§ 25.21),
which may result in significant
environmental impacts, may exist for
some actions that are usually
categorically excluded. An EA provides
information that is used to determine
whether an FDA action could result in
a significant environmental impact.
Sections 25.40(a) and (c) specifies the
content requirements for EAs for
nonexcluded actions.
This collection of information is used
by FDA to assess the environmental
impact of agency actions and to ensure
that the public is informed of
environmental analyses. Firms wishing
to manufacture and market substances
regulated under statutes for which FDA
is responsible must, in most instances,
submit applications requesting
approval. Environmental information
must be included in such applications
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
for the purpose of determining whether
the proposed action may have a
significant impact on the environment.
Where significant adverse effects cannot
be avoided, the agency uses the
submitted information as the basis for
preparing and circulating to the public
an EIS, made available through a
Federal Register document also filed for
comment at the Environmental
Protection Agency (EPA). The final EIS,
including the comments received, is
reviewed by the agency to weigh
environmental costs and benefits in
determining whether to pursue the
proposed action or some alternative that
would reduce expected environmental
impact. Any final EIS would contain
additional information gathered by the
agency after the publication of the draft
EIS, a copy of or a summary of the
comments received on the draft EIS, and
the agency’s responses to the comments,
including any revisions resulting from
the comments or other information.
When the agency finds that no
significant environmental effects are
expected, the agency prepares a finding
of no significant impact (FONSI).
Estimated Annual Reporting Burden for
Human Drugs
Under 21 CFR 312.23(a)(7)(iv)(e),
314.50(d)(1)(iii), and 314.94(a)(9)(i),
each investigational new drug
application (IND), new drug application
(NDA), and abbreviated new drug
application (ANDA) must contain a
claim for categorical exclusion under
§ 25.30 or § 25.31 or an EA under
§ 25.40. In 2005, FDA received 1,933
INDs from 1,517 sponsors, 114 NDAs
from 94 applicants, 2,682 supplements
to NDAs from 293 applicants, 777
ANDAs from 161 applicants, and 4,318
supplements to ANDAs from 219
applicants. FDA estimates that it
receives approximately 9,813 claims for
categorical exclusions as required under
§ 25.15(a) and (d), and 11 EAs as
required under § 25.40(a) and (c). Based
on information provided by the
pharmaceutical industry, FDA estimates
that it takes sponsors or applicants
approximately 8 hours to prepare a
claim for a categorical exclusion and
approximately 3,400 hours to prepare an
EA.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\29MRN1.SGM
29MRN1
15755
Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Estimated Annual Reporting Burden for Human Drugs
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Burden
Hours
25.15(a) and (d)
2,284
4.32
9,813
8
78,504
25.40(a) and (c)
11
1
11
3,400
37,400
Total
1There
115,904
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Human Foods
Under 21 CFR 71.1, 171.1, 170.39, and
170.100, food additive petitions, color
additive petitions, requests for
exemption from regulation as a food
additive, and submission of a food
contact notification (FCN) for a food
contact substance must contain either a
claim of categorical exclusion under
§ 25.30 or § 25.32, or an EA under
§ 25.40. From 2003 to 2005, FDA
received an annual average of 88
industry submissions. FDA estimates
that it received an annual average of 57
claims of categorical exclusions as
required under § 25.15(a) and (d), and
31 EAs as required under § 25.40(a) and
(c). FDA estimates that, on average, it
takes petitioners, notifiers, or requestors
approximately 3 hours to prepare a
claim of categorical exclusion and
approximately 210 hours to prepare an
EA.
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1
Estimated Annual Reporting Burden for Human Foods
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Burden
Hours
25.15(a) and (d)
57
1.4
80
3
240
25.40(a) and (c)
31
1.3
39
210
8,190
Total
1There
8,430
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Medical Devices
Under 21 CFR 814.20(b)(11),
premarket approvals (original premarket
approval applications (PMAs) and
supplements) must contain a claim for
categorical exclusion under § 25.30 or
§ 25.34 or an EA under § 25.40. In 2005,
FDA received 282 claims (original
PMAs and supplements) for categorical
exclusions as required under § 25.15(a)
and (d), and 0 EAs as required under
§ 25.40(a) and (c). Based on information
provided by less than 10 sponsors, FDA
estimates that it takes approximately
less than 1 hour to prepare a claim for
a categorical exclusion and an unknown
number of hours to prepare an EA.
TABLE 3.—ESTIMATED ANNUAL REPORTING BURDEN1
Estimated Annual Reporting Burden for Medical Devices
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Burden
Hours
25.15(a) and (d)
47
6
282
1
282
25.40(a) and (c)
0
0
0
0
0
Total
hsrobinson on PROD1PC68 with NOTICES
1There
282
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Biological Products
Under 21 CFR 312.23(a)(7)(iv)(e) and
601.2(a), IND and biologics license
applications (BLAs) must contain a
claim for categorical exclusion under
§ 25.30 or § 25.31 or an EA under
§ 25.40. In 2005, FDA received 565 INDs
from 426 sponsors, 27 BLAs from 12
VerDate Aug<31>2005
15:39 Mar 28, 2006
Jkt 208001
applicants, and 737 BLA supplements to
license applications from 205
applicants. FDA estimates that
approximately 10 percent of these
supplements would be submitted with a
claim for categorical exclusion or an EA.
FDA estimates that it received
approximately 666 claims for categorical
exclusion as required under § 25.15(a)
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
and (d), and 2 EAs as required under
§ 25.40(a) and (c). Based on information
provided by industry, FDA estimates
that it takes sponsors and applicants
approximately 8 hours to prepare a
claim for categorical exclusion and
approximately 3,400 hours to prepare an
EA for a biological product.
E:\FR\FM\29MRN1.SGM
29MRN1
15756
Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices
TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN1
Estimated Annual Reporting Burden for Biological Products
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Burden
Hours
25.15(a) and (d)
459
1.45
666
8
5,328
25.40(a) and (c)
2
1
2
3,400
6,800
Total
1There
12,128
are no capital costs or operating and maintenance costs associated with this collection of information.
§ 570.35 (c)(1)(viii) generally recognized
as safe (GRAS) affirmation petitions,
and § 571.1(c) food additive petitions
must contain a claim for categorical
exclusion under § 25.30 or § 25.33 or an
EA under § 25.40. In 2005, FDA’s Center
for Veterinary Medicine (CVM) has
received approximately 421 claims for
categorical exclusion as required under
Estimated Annual Reporting Burden for
Animal Drugs
Under 21 CFR 514.1(b)(14), new
animal drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs), § 514.8(a)(1)
supplemental NADAs and ANADAs,
§ 511.1 (b)(10) investigational new
animal drug applications (INADs),
§ 25.15(a) and (d), and 14 EAs as
required under § 25.40(a) and (c). Based
on information provided by industry,
FDA estimates that it takes sponsors/
applicants approximately 8 hours to
prepare a claim for a categorical
exclusion and an average of 2,160 hours
to prepare an EA.
TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN1
Estimated Annual Reporting Burden for Animal Drugs
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Burden
Hours
25.15(a) and (d)
135
3.9
421
8
3,368
25.40(a) and (c)
12
1.6
14
2,160
30,240
Total
1There
33,608
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on information provided by
industry, FDA estimates that the
combined annual total burden hours for
all Centers is 170,352.
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–4507 Filed 3–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Bureau of Customs and Border
Protection
Automated Commercial Environment
(ACE): Ability of Truck Carriers To Use
Third Parties To Submit Manifest
Information in the Test of the ACE
Truck Manifest System
Customs and Border Protection,
Department of Homeland Security.
ACTION: General notice.
hsrobinson on PROD1PC68 with NOTICES
AGENCY:
SUMMARY: This document announces
that the Bureau of Customs and Border
Protection (CBP) will permit truck
carriers who are not Automated
VerDate Aug<31>2005
15:39 Mar 28, 2006
Jkt 208001
Commercial Environment (ACE) Truck
Carrier Accounts to use third parties to
transmit truck manifest information on
their behalf electronically in the ACE
Truck Manifest system, via electronic
data interchange (EDI) messaging. Truck
carriers electing to use a third party to
submit manifest information to CBP
must possess a valid Standard Carrier
Alpha Code (SCAC) from the National
Motor Freight Traffic Association. Truck
carriers who elect to use this
transmission method will not have
access to operational data and will not
receive status messages on ACE
transactions, nor will they have access
to integrated Account data from
multiple system sources. These truck
carriers will be able to obtain release of
their cargo, crew, conveyances, and
equipment via EDI messaging back to
the transmitter of the information. By
making these changes, CBP is opening
the test to parties previously ineligible
to participate.
Effective Date: Truck carriers
will be able to participate in ACE
through the use of a third party
transmitter starting on March 29, 2006.
DATES:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Mr.
James Swanson, via e-mail at
james.d.swanson@dhs.gov.
SUPPLEMENTARY INFORMATION:
Background
On February 4, 2004 and September
13, 2004, CBP published General
Notices in the Federal Register (69 FR
55167 and 69 FR 5360) announcing a
test, in conjunction with the Federal
Motor Carrier Safety Administration
(FMCSA), allowing participating truck
carriers to transmit electronic manifest
data in ACE, including advance cargo
information as required by section
343(a) of the Trade Act of 2002, as
amended by the Maritime
Transportation Security Act of 2002 (see
68 FR 68140). The advance cargo
information requirements are detailed in
the final rule published in the Federal
Register at 68 FR 68140 on December 5,
2003. Truck carriers participating in the
test opened up Truck Carrier Accounts
which provided them with the ability to
electronically transmit truck manifest
data and obtain release of their cargo,
crew, conveyances, and equipment via
the ACE Portal or electronic data
interchange (EDI) messaging.
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 71, Number 60 (Wednesday, March 29, 2006)]
[Notices]
[Pages 15753-15756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4507]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0105]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Environmental Impact Considerations
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 information collection
contained in FDA regulations entitled ``Environmental Impact
Considerations.''
[[Page 15754]]
DATES: Submit written or electronic comments on the collection of
information by May 30, 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 20857. All comments should be identified with the docket
number found in brackets in the heading of this document.
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.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(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.
Environmental Impact Considerations--Part 25 (21 CFR Part 25) (OMB
Control Number 0910-0322)--Extension
FDA is requesting OMB approval for the reporting requirements
contained in the FDA regulation ``Environmental Impact
Considerations.''
The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347),
states national environmental objectives and imposes upon each Federal
agency the duty to consider the environmental effects of its actions.
Section 102(2)(C) of NEPA requires the preparation of an environmental
impact statement (EIS) for every major Federal action that will
significantly affect the quality of the human environment.
The FDA NEPA regulations are at part 25. All applications or
petitions requesting agency action require the submission of a claim
for a categorical exclusion or an environmental assessment (EA). A
categorical exclusion applies to certain classes of FDA-regulated
actions that usually have little or no potential to cause significant
environmental effects and are excluded from the requirements to prepare
an EA or EIS. Section 25.15(a) and (d) specifies the procedures for
submitting to FDA a claim for a categorical exclusion. Extraordinary
circumstances (Sec. 25.21), which may result in significant
environmental impacts, may exist for some actions that are usually
categorically excluded. An EA provides information that is used to
determine whether an FDA action could result in a significant
environmental impact. Sections 25.40(a) and (c) specifies the content
requirements for EAs for nonexcluded actions.
This collection of information is used by FDA to assess the
environmental impact of agency actions and to ensure that the public is
informed of environmental analyses. Firms wishing to manufacture and
market substances regulated under statutes for which FDA is responsible
must, in most instances, submit applications requesting approval.
Environmental information must be included in such applications for the
purpose of determining whether the proposed action may have a
significant impact on the environment. Where significant adverse
effects cannot be avoided, the agency uses the submitted information as
the basis for preparing and circulating to the public an EIS, made
available through a Federal Register document also filed for comment at
the Environmental Protection Agency (EPA). The final EIS, including the
comments received, is reviewed by the agency to weigh environmental
costs and benefits in determining whether to pursue the proposed action
or some alternative that would reduce expected environmental impact.
Any final EIS would contain additional information gathered by the
agency after the publication of the draft EIS, a copy of or a summary
of the comments received on the draft EIS, and the agency's responses
to the comments, including any revisions resulting from the comments or
other information. When the agency finds that no significant
environmental effects are expected, the agency prepares a finding of no
significant impact (FONSI).
Estimated Annual Reporting Burden for Human Drugs
Under 21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i), each investigational new drug application (IND), new
drug application (NDA), and abbreviated new drug application (ANDA)
must contain a claim for categorical exclusion under Sec. 25.30 or
Sec. 25.31 or an EA under Sec. 25.40. In 2005, FDA received 1,933
INDs from 1,517 sponsors, 114 NDAs from 94 applicants, 2,682
supplements to NDAs from 293 applicants, 777 ANDAs from 161 applicants,
and 4,318 supplements to ANDAs from 219 applicants. FDA estimates that
it receives approximately 9,813 claims for categorical exclusions as
required under Sec. 25.15(a) and (d), and 11 EAs as required under
Sec. 25.40(a) and (c). Based on information provided by the
pharmaceutical industry, FDA estimates that it takes sponsors or
applicants approximately 8 hours to prepare a claim for a categorical
exclusion and approximately 3,400 hours to prepare an EA.
FDA estimates the burden of this collection of information as
follows:
[[Page 15755]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Burden for Human Drugs
---------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per Total Burden
21 CFR Section Respondents per Response Responses Response Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 2,284 4.32 9,813 8 78,504
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c) 11 1 11 3,400 37,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 115,904
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for Human Foods
Under 21 CFR 71.1, 171.1, 170.39, and 170.100, food additive
petitions, color additive petitions, requests for exemption from
regulation as a food additive, and submission of a food contact
notification (FCN) for a food contact substance must contain either a
claim of categorical exclusion under Sec. 25.30 or Sec. 25.32, or an
EA under Sec. 25.40. From 2003 to 2005, FDA received an annual average
of 88 industry submissions. FDA estimates that it received an annual
average of 57 claims of categorical exclusions as required under Sec.
25.15(a) and (d), and 31 EAs as required under Sec. 25.40(a) and (c).
FDA estimates that, on average, it takes petitioners, notifiers, or
requestors approximately 3 hours to prepare a claim of categorical
exclusion and approximately 210 hours to prepare an EA.
Table 2.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Burden for Human Foods
---------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per Total Burden
21 CFR Section Respondents per Response Responses Response Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 57 1.4 80 3 240
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c) 31 1.3 39 210 8,190
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 8,430
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for Medical Devices
Under 21 CFR 814.20(b)(11), premarket approvals (original premarket
approval applications (PMAs) and supplements) must contain a claim for
categorical exclusion under Sec. 25.30 or Sec. 25.34 or an EA under
Sec. 25.40. In 2005, FDA received 282 claims (original PMAs and
supplements) for categorical exclusions as required under Sec.
25.15(a) and (d), and 0 EAs as required under Sec. 25.40(a) and (c).
Based on information provided by less than 10 sponsors, FDA estimates
that it takes approximately less than 1 hour to prepare a claim for a
categorical exclusion and an unknown number of hours to prepare an EA.
Table 3.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Burden for Medical Devices
---------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per Total Burden
21 CFR Section Respondents per Response Responses Response Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 47 6 282 1 282
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c) 0 0 0 0 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 282
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for Biological Products
Under 21 CFR 312.23(a)(7)(iv)(e) and 601.2(a), IND and biologics
license applications (BLAs) must contain a claim for categorical
exclusion under Sec. 25.30 or Sec. 25.31 or an EA under Sec. 25.40.
In 2005, FDA received 565 INDs from 426 sponsors, 27 BLAs from 12
applicants, and 737 BLA supplements to license applications from 205
applicants. FDA estimates that approximately 10 percent of these
supplements would be submitted with a claim for categorical exclusion
or an EA.
FDA estimates that it received approximately 666 claims for
categorical exclusion as required under Sec. 25.15(a) and (d), and 2
EAs as required under Sec. 25.40(a) and (c). Based on information
provided by industry, FDA estimates that it takes sponsors and
applicants approximately 8 hours to prepare a claim for categorical
exclusion and approximately 3,400 hours to prepare an EA for a
biological product.
[[Page 15756]]
Table 4.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Burden for Biological Products
---------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per Total Burden
21 CFR Section Respondents per Response Responses Response Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 459 1.45 666 8 5,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c) 2 1 2 3,400 6,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 12,128
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for Animal Drugs
Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs), Sec. 514.8(a)(1)
supplemental NADAs and ANADAs, Sec. 511.1 (b)(10) investigational new
animal drug applications (INADs), Sec. 570.35 (c)(1)(viii) generally
recognized as safe (GRAS) affirmation petitions, and Sec. 571.1(c)
food additive petitions must contain a claim for categorical exclusion
under Sec. 25.30 or Sec. 25.33 or an EA under Sec. 25.40. In 2005,
FDA's Center for Veterinary Medicine (CVM) has received approximately
421 claims for categorical exclusion as required under Sec. 25.15(a)
and (d), and 14 EAs as required under Sec. 25.40(a) and (c). Based on
information provided by industry, FDA estimates that it takes sponsors/
applicants approximately 8 hours to prepare a claim for a categorical
exclusion and an average of 2,160 hours to prepare an EA.
Table 5.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Burden for Animal Drugs
---------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per Total Burden
21 CFR Section Respondents per Response Responses Response Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 135 3.9 421 8 3,368
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c) 12 1.6 14 2,160 30,240
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 33,608
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on information provided by industry, FDA estimates that the
combined annual total burden hours for all Centers is 170,352.
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4507 Filed 3-28-06; 8:45 am]
BILLING CODE 4160-01-S
