Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations, 59619-59622 [2012-23838]
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59619
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
II. Annual AIC Adjustments
B. Calendar Year 2013
A. AIC Adjustment Formula and AIC
Adjustments
The AIC threshold amount for ALJ
hearing requests will increase to $140
and the AIC threshold amount for
judicial review will rise to $1,400 for CY
2013. These updated amounts are based
on the 40.04 percent increase in the
medical care component of the CPI from
July 2003 to July 2012. The CPI level
was at 297.600 in July 2003 and rose to
416.759 in July 2012. This change
accounted for the 40.04 percent
increase. The AIC threshold amount for
ALJ hearing requests changes to $140.04
based on the 40.04 percent increase. In
As previously noted, section 940 of
the MMA requires that the AIC
threshold amounts be adjusted
annually, beginning in January 2005, by
the percentage increase in the medical
care component of the consumer price
index (CPI) for all urban consumers
(U.S. city average) for July 2003 to July
of the year preceding the year involved
and rounded to the nearest multiple of
$10.
CY 2009
ALJ Hearing .........................................................................
Judicial Review ....................................................................
III. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: September 12, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–23992 Filed 9–27–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0961]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
srobinson on DSK4SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
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
SUMMARY:
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CY 2010
$120
1,220
Frm 00030
Fmt 4703
Sfmt 4703
C. Summary Table of Adjustments in
the AIC Threshold Amounts
In the following table we list the CYs
2009 through 2013 threshold amounts.
CY 2011
$130
1,260
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 entitled
‘‘Environmental Impact
Considerations.’’
DATES: Submit either electronic or
written comments on the collection of
information by November 27, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
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
PO 00000
accordance with section 940 of the
MMA, this amount is rounded to the
nearest multiple of $10. Therefore, the
CY 2013 AIC threshold amount for ALJ
hearings is $140. The AIC threshold
amount for judicial review changes to
$1,400.40 based on the 40.04 percent
increase. This amount was rounded to
the nearest multiple of $10, resulting in
the CY 2013 AIC threshold amount of
$1,400 for judicial review.
$130
1,300
CY 2012
$130
1,350
CY 2013
$140
1,400
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—21 CFR Part 25 (OMB
Control Number 0910–0322)—
Extension)
FDA is requesting OMB approval for
the reporting requirements contained in
the FDA collection of information
‘‘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
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Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
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.
FDA’s NEPA regulations are in part 25
(21 CFR part 25). All applications or
petitions requesting Agency action
require the submission of a claim for
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. Section 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 statues 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 events 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. 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 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.
FDA estimates the burden of this
collection of information as follows:
Estimated Annual Reporting Burden for
Human Drugs (Including Biologics in
the Center for Drug Evaluation and
Research)
Under 21 CFR 312.23(a)(7)(iv)(3), 21
CFR 314.50(d)(1)(iii), and 21 CFR
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
2011, FDA received 2,818 INDs from
2,064 sponsors, 99 NDAs from 79
applicants, 3,247 supplements to NDAs
from 376 applicants, 5 biologic license
applications (BLAs) from 5 applicants,
287 supplements to BLAs from 50
applicants, 895 ANDAs from 195
applicants, and 5,348 supplements to
ANDAs from 299 applicants. FDA
estimates that it receives approximately
12,699 claims for categorical exclusions
as required under 25.15(a) and (d), and
10 EAs as required under 25.40(a) and
(c). Therefore, over the next 3 years,
FDA estimates that approximately 3,175
respondents will submit an average of 4
applications for categorical exclusion
and 10 respondents will submit an
average of 1 EA. 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.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15(a) and (d) ...................................................................
25.40(a) and (c) ...................................................................
3,175
10
4
1
12,700
10
8
3,400
101,600
34,000
Total ..............................................................................
........................
........................
........................
........................
135,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
srobinson on DSK4SPTVN1PROD with NOTICES
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 from
exemption from regulation as a food
additive, and submission of a food
contact notification 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. In 2011,
FDA received 97 industry submissions.
FDA received an annual average of 42
claims of categorical exclusions as
required under 25.15(a) and (d), and 33
EAs as required under 25.40(a) and (c).
Therefore, over the next 3 years, FDA
estimates that approximately 42
respondents will submit an average of 1
application for categorical exclusion
and 33 respondents will submit an
average of 1 EA. 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 FOR HUMAN FOODS 1
Number of
respondents
21 CFR Section
25.15(a) and (d) ...................................................................
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Number of
responses per
respondent
42
Fmt 4703
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Total annual
responses
1
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42
28SEN1
Average
burden per
response
Total hours
8
336
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Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN FOODS 1—Continued
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.40(a) and (c) ...................................................................
33
1
33
210
6,930
Total ..............................................................................
........................
........................
........................
........................
7,266
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 (PMA) (original
PMAs and supplements) must contain a
claim for categorical exclusion under
FDA estimates that approximately 52
respondents will submit an average of 1
application for categorical exclusion.
Based on information provided by less
than 10 sponsors, FDA estimates that it
takes approximately 6 hours to prepare
a claim for a categorical exclusion.
25.30 or 25.34 or an EA under 25.40. In
2011, FDA received approximately 52
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). Therefore, over the next 3 years,
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR MEDICAL DEVICES 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15 (a) and (d) ..................................................................
52
1
52
6
312
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Biological Products, Drugs, and Medical
Devices in the Center for Biologics
Evaluation and Research
BLAs under 21 CFR 601.2(a), as well
as INDs (21 CFR 312.23), NDAs (21 CFR
314.50), ANDAs (21 CFR 314.94), and
PMAs (21 CFR 814.20), must contain
either a claim of categorical exclusion
under 25.30 or 25.32 or an EA under
25.40. In 2011, FDA received 14 BLAs
from 14 applicants, 831 BLA
supplements to license applications
from 153 applicants, 288 INDs from 210
sponsors, 1 NDA from 1 applicant, 37
supplements to NDAs from 9 applicants,
1 ANDA from 1 applicant, 12
supplements to ANDAs from 2
applicants, and 45 PMA supplements
from 11 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 481 claims for categorical
exclusion as required under 25.15(a)
and (d), and 2 EAs as required under
25.40(a) and (c). Therefore, over the next
3 years, FDA estimates that
approximately 247 respondents will
submit an average of 2 applications for
categorical exclusion and 2 respondents
will submit an average of 1 EA. Based
on information provided by industry,
FDA estimates that it takes sponsors and
applicants approximately 8 hours to
prepare a claim of categorical exclusion
and approximately 3,400 hours to
prepare an EA for a biological product.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15 (a) and (d) ..................................................................
25.40 (a) and (c) ..................................................................
247
2
2
1
494
2
8
3,400
3,952
6,800
Total ..............................................................................
........................
........................
........................
........................
10,752
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
srobinson on DSK4SPTVN1PROD with NOTICES
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), 21 CFR
514.8(a)(1) supplemental NADAs and
ANADAs, 21 CFR 511.1(b)(10)
investigational new animal drug
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applications (INADs), and 21 CFR
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 2011, FDA’s Center for
Veterinary Medicine has received
approximately 698 claims for categorical
exclusion as required under 25.15(a)
and (d), and 10 EAs as required under
25.40(a) and (c). Therefore, over the next
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
3 years, FDA estimates that
approximately 70 respondents will
submit an average of 10 applications for
categorical exclusion and 10
respondents will submit an average of 1
EA. FDA estimates that it takes
sponsors/applicants approximately 3
hours to prepare a claim of categorical
exclusion and an average of 2,160 hours
to prepare an EA.
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Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15 (a) and (d) ..................................................................
25.40 (a) and (c) ..................................................................
70
10
10
1
700
10
3
2,160
2,100
21,600
Total ..............................................................................
........................
........................
........................
........................
23,700
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Tobacco Products
Under sections 905, 910, and 911 of
the Federal Food, Drugs, and Cosmetic
Act, premarket tobacco applications
(PMTAs), applications for substantial
equivalence (SEs), Exemption from SEs,
and modified risk tobacco products
must contain a claim for categorical
exclusion under 25.30 or 25.34 or an EA
under 25.40. In 2011, FDA estimated it
will receive approximately 20 PMTAs
and supplements from 20 respondents,
150 reports intended to demonstrate the
SE of a new tobacco product from 150
respondents, 500 exemption from SE
requirements applications from 500
respondents, and 3 modified risk
Tobacco product applications from 3
respondents for a total of 673 responses
from 673 respondents. FDA estimates
that there were 538 claims from 538
respondents for categorical exclusions
as required under 25.15(a) and (d), and
135 EAs from 135 respondents as
required under 25.40(a) and (c).
Therefore, over the next 3 years, FDA
estimates that approximately 538
respondents will submit an average of 1
application for categorical exclusion
and 135 respondents will submit an
average of 1 EA. Based on FDA’s
experience and previous information
provided by potential sponsors, FDA
estimates that it takes approximately 12
hours to prepare a claim for a
categorical exclusion and 12 hours to
prepare an EA.
TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15 (a) and (d) ..................................................................
25.40 (a) and (c) ..................................................................
538
135
1
1
538
135
12
12
6,456
1,620
Total ..............................................................................
........................
........................
........................
........................
8,076
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 7—ESTIMATED ANNUAL TOTAL REPORTING BURDEN FOR ALL CENTERS 1
Number of
respondents
CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15 (a) and (d) ..................................................................
25.40 (a) and (c) ..................................................................
4,124
190
........................
........................
14,526
190
........................
........................
114,756
70,950
Total ..............................................................................
........................
........................
........................
........................
185,706
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–23838 Filed 9–27–12; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2012–N–0977]
BILLING CODE 4160–01–P
srobinson on DSK4SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
regulations restricting the sale and
distribution of cigarettes and smokeless
tobacco to protect children and
adolescents.
The Food and Drug
Administration (FDA) is announcing an
SUMMARY:
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]]>Agencies
[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59619-59622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23838]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0961]
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
entitled ``Environmental Impact Considerations.''
DATES: Submit either electronic or written comments on the collection
of information by November 27, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@fda.hhs.gov.
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--21 CFR Part 25 (OMB Control Number
0910-0322)--Extension)
FDA is requesting OMB approval for the reporting requirements
contained in the FDA collection of information ``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
[[Page 59620]]
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.
FDA's NEPA regulations are in part 25 (21 CFR part 25). All
applications or petitions requesting Agency action require the
submission of a claim for 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. Section 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 statues 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 events
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. 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 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.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden for Human Drugs (Including Biologics
in the Center for Drug Evaluation and Research)
Under 21 CFR 312.23(a)(7)(iv)(3), 21 CFR 314.50(d)(1)(iii), and 21
CFR 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 2011, FDA received 2,818 INDs from 2,064
sponsors, 99 NDAs from 79 applicants, 3,247 supplements to NDAs from
376 applicants, 5 biologic license applications (BLAs) from 5
applicants, 287 supplements to BLAs from 50 applicants, 895 ANDAs from
195 applicants, and 5,348 supplements to ANDAs from 299 applicants. FDA
estimates that it receives approximately 12,699 claims for categorical
exclusions as required under 25.15(a) and (d), and 10 EAs as required
under 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates
that approximately 3,175 respondents will submit an average of 4
applications for categorical exclusion and 10 respondents will submit
an average of 1 EA. 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.
Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................ 3,175 4 12,700 8 101,600
25.40(a) and (c)................ 10 1 10 3,400 34,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 135,600
----------------------------------------------------------------------------------------------------------------
\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 from exemption from
regulation as a food additive, and submission of a food contact
notification 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. In
2011, FDA received 97 industry submissions. FDA received an annual
average of 42 claims of categorical exclusions as required under
25.15(a) and (d), and 33 EAs as required under 25.40(a) and (c).
Therefore, over the next 3 years, FDA estimates that approximately 42
respondents will submit an average of 1 application for categorical
exclusion and 33 respondents will submit an average of 1 EA. 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 for Human Foods \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................ 42 1 42 8 336
[[Page 59621]]
25.40(a) and (c)................ 33 1 33 210 6,930
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 7,266
----------------------------------------------------------------------------------------------------------------
\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 (PMA) (original
PMAs and supplements) must contain a claim for categorical exclusion
under 25.30 or 25.34 or an EA under 25.40. In 2011, FDA received
approximately 52 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). Therefore, over the next 3 years, FDA estimates
that approximately 52 respondents will submit an average of 1
application for categorical exclusion. Based on information provided by
less than 10 sponsors, FDA estimates that it takes approximately 6
hours to prepare a claim for a categorical exclusion.
Table 3--Estimated Annual Reporting Burden for Medical Devices \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15 (a) and (d).................................................. 52 1 52 6 312
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for Biological Products, Drugs, and
Medical Devices in the Center for Biologics Evaluation and Research
BLAs under 21 CFR 601.2(a), as well as INDs (21 CFR 312.23), NDAs
(21 CFR 314.50), ANDAs (21 CFR 314.94), and PMAs (21 CFR 814.20), must
contain either a claim of categorical exclusion under 25.30 or 25.32 or
an EA under 25.40. In 2011, FDA received 14 BLAs from 14 applicants,
831 BLA supplements to license applications from 153 applicants, 288
INDs from 210 sponsors, 1 NDA from 1 applicant, 37 supplements to NDAs
from 9 applicants, 1 ANDA from 1 applicant, 12 supplements to ANDAs
from 2 applicants, and 45 PMA supplements from 11 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 481 claims for
categorical exclusion as required under 25.15(a) and (d), and 2 EAs as
required under 25.40(a) and (c). Therefore, over the next 3 years, FDA
estimates that approximately 247 respondents will submit an average of
2 applications for categorical exclusion and 2 respondents will submit
an average of 1 EA. Based on information provided by industry, FDA
estimates that it takes sponsors and applicants approximately 8 hours
to prepare a claim of categorical exclusion and approximately 3,400
hours to prepare an EA for a biological product.
Table 4--Estimated Annual Reporting Burden for Biological Products \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15 (a) and (d)............... 247 2 494 8 3,952
25.40 (a) and (c)............... 2 1 2 3,400 6,800
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 10,752
----------------------------------------------------------------------------------------------------------------
\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), 21 CFR 514.8(a)(1)
supplemental NADAs and ANADAs, 21 CFR 511.1(b)(10) investigational new
animal drug applications (INADs), and 21 CFR 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 2011, FDA's Center for Veterinary
Medicine has received approximately 698 claims for categorical
exclusion as required under 25.15(a) and (d), and 10 EAs as required
under 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates
that approximately 70 respondents will submit an average of 10
applications for categorical exclusion and 10 respondents will submit
an average of 1 EA. FDA estimates that it takes sponsors/applicants
approximately 3 hours to prepare a claim of categorical exclusion and
an average of 2,160 hours to prepare an EA.
[[Page 59622]]
Table 5--Estimated Annual Reporting Burden for Animal Drugs \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15 (a) and (d)............... 70 10 700 3 2,100
25.40 (a) and (c)............... 10 1 10 2,160 21,600
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 23,700
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Estimated Annual Reporting Burden for Tobacco Products
Under sections 905, 910, and 911 of the Federal Food, Drugs, and
Cosmetic Act, premarket tobacco applications (PMTAs), applications for
substantial equivalence (SEs), Exemption from SEs, and modified risk
tobacco products must contain a claim for categorical exclusion under
25.30 or 25.34 or an EA under 25.40. In 2011, FDA estimated it will
receive approximately 20 PMTAs and supplements from 20 respondents, 150
reports intended to demonstrate the SE of a new tobacco product from
150 respondents, 500 exemption from SE requirements applications from
500 respondents, and 3 modified risk Tobacco product applications from
3 respondents for a total of 673 responses from 673 respondents. FDA
estimates that there were 538 claims from 538 respondents for
categorical exclusions as required under 25.15(a) and (d), and 135 EAs
from 135 respondents as required under 25.40(a) and (c). Therefore,
over the next 3 years, FDA estimates that approximately 538 respondents
will submit an average of 1 application for categorical exclusion and
135 respondents will submit an average of 1 EA. Based on FDA's
experience and previous information provided by potential sponsors, FDA
estimates that it takes approximately 12 hours to prepare a claim for a
categorical exclusion and 12 hours to prepare an EA.
Table 6--Estimated Annual Reporting Burden for Tobacco Products \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15 (a) and (d)............... 538 1 538 12 6,456
25.40 (a) and (c)............... 135 1 135 12 1,620
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 8,076
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 7--Estimated Annual Total Reporting Burden for All Centers \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15 (a) and (d)............... 4,124 .............. 14,526 .............. 114,756
25.40 (a) and (c)............... 190 .............. 190 .............. 70,950
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 185,706
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23838 Filed 9-27-12; 8:45 am]
BILLING CODE 4160-01-P
