Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations, 11892-11895 [2013-03836]
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11892
Federal Register / Vol. 78, No. 34 / Wednesday, February 20, 2013 / Notices
Consultation Sessions to all Tribal
Governments receiving funds for Head
Start and Early Head Start programs.
Tribes wishing to submit written
testimony for the report should send
testimony to Robert Bialas at
Robert.Bialas@acf.hhs.gov either prior
to the Consultation Session or within 30
days after the meeting.
Oral testimony and comments from
the Consultation Sessions will be
summarized in each report without
attribution, along with topics of concern
and recommendations. Hotel and
logistical information for the
Consultation Sessions has been sent to
tribal leaders via email and posted on
the Early Childhood Learning and
Knowledge Center Web site at
eclkc.ohs.acf.hhs.gov/hslc/
eclkc_main_calendar/tc-2013.
Dated: February 11, 2013.
Yvette Sanchez Fuentes,
Director, Office of Head Start.
[FR Doc. 2013–03795 Filed 2–19–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0961]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by March 22,
2013.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0322. Also
include the FDA docket number found
in brackets in the heading of this
document.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Environmental Impact
Considerations—(OMB Control Number
0910–0322)—Revision
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. 4321–4327) 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.
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 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 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
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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.
In the Federal Register of September
28, 2012 (77 FR 59619), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Two comments that were
PRA related were received from one
commenter.
(Comment 1) The commenter
indicated that FDA underestimates the
hours required to complete an
environmental assessment for tobacco
products, and that FDA’s 12 hours
burden estimate per response is
substantially underestimated. The
commenter said, based on the
commenter’s experience, an
environmental assessment for tobacco
products should take approximately 80
hours to complete.
(Response 1) FDA agrees with this
comment. Upon further review of the
number of hours required to complete
an environmental assessment for
tobacco products, FDA has determined
that 12 hours is too low an estimate and
has revised the burden estimate per
response for completing an
environmental assessment for tobacco
products from 12 to 80 hours. This
revision was based upon revisiting this
estimate with the Center for Tobacco
Products staff and this comment.
Rethinking the time to prepare an
environmental assessment for tobacco
products resulted in revising the burden
per response to 80 hours.
(Comment 2) The commenter also
encouraged the Agency to establish
categorical exclusions for environmental
assessments for tobacco product
submittals under section 905(j) of the
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Federal Register / Vol. 78, No. 34 / Wednesday, February 20, 2013 / Notices
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 387e(j)).
(Response 2) FDA has decided to not
establish categorical exclusions for
tobacco products at this time.
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)(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 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 will receive
approximately 15,699 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.
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
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15(a) and (d) ...................................................................
25.40(a) and (c) ...................................................................
42
33
1
1
42
33
8
210
336
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.
srobinson on DSK4SPTVN1PROD with NOTICES
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.
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Federal Register / Vol. 78, No. 34 / Wednesday, February 20, 2013 / Notices
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 (§ 312.23), NDAs (§ 314.50),
ANDAs (§ 314.94), and PMAs (§ 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, and 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.
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.
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.
srobinson on DSK4SPTVN1PROD with NOTICES
Estimated Annual Reporting Burden for
Tobacco Products
Under sections 905, 910, and 911 of
the FD&C Act (21 U.S.C. 387j and 387k),
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. When estimating the
burden for tobacco products, FDA
considered the environmental impacts
associated with different applications.
Specifically, in 2011, FDA estimated it
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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 exemptions from SE
requirements applications from 500
respondents, and 3 modified risk
tobacco product applications from 3
respondents. FDA is also not accepting
claims for categorical exclusions at this
time, and estimates that there will be
135 EAs from 135 respondents as
required under § 25.40(a) and (c).
Therefore, over the next 3 years, FDA
estimates that approximately 135
respondents will submit an average of 1
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application for environmental
assessment. Part of the information in
the EA will be developed while writing
other parts of a PMTA, SE., exemption
from SE, or modified risk tobacco
product application. Based on FDA’s
experience, previous information
provided by potential sponsors,
information provided by a commenter to
this collection of information, and
knowledge that part of the EA
information has already been produced
in one of the tobacco product
applications, FDA estimates that it takes
approximately 80 hours to prepare an
EA.
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Federal Register / Vol. 78, No. 34 / Wednesday, February 20, 2013 / Notices
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
25.40(a) and (c) ...................................................................
135
1
135
80
10,800
Total ..............................................................................
........................
........................
........................
........................
10,800
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
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) ...................................................................
3,586
190
........................
........................
13,998
190
........................
........................
108,300
80,130
Total ..............................................................................
........................
........................
........................
........................
188,430
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
The prospective exclusive license
territory may be worldwide and the
field of use will be limited to the use of
Licensed Patent Rights for development
of Pox-virus based vaccines for bladder
cancer, breast cancer, colorectal cancer,
gastric cancer, kidney cancer, liver
cancer, lung cancer, ovarian cancer,
prostate cancer and pancreatic cancer.’’
[FR Doc. 2013–03836 Filed 2–19–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Prospective Grant of Exclusive
License: Development of MUC–1
Tumor Associated Antigens as Cancer
Vaccines for Bladder Cancer, Breast
Cancer, Colorectal Cancer, Gastric
Cancer, Kidney Cancer, Liver Cancer,
Lung Cancer, Ovarian Cancer, Prostate
Cancer and Pancreatic Cancer
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in the following U.S. Patents
and Patent Applications to Bavarian
Nordic Immunotherapeutics (‘‘BNIT’’)
located in Mountain View, CA, USA:
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
Intellectual Property: U.S. provisional
patent application no. 61/582, 723 filed
January 3, 2012 entitled ‘‘Native and Agonist
CTL Epitopes of the MUC–1 Tumor Antigen’’
[HHS Ref. No. E–001–2012/0–US–01] as well
as all international applications, continuation
applications and divisional applications.
The patent rights in these inventions
have been assigned to the government of
the United States of America.
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Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before March
22, 2013 will be considered.
DATES:
National Institutes of Health
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Sabarni K. Chatterjee, Ph.D., M.B.A.
Licensing and Patenting Manager,
Cancer Branch, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–5587; Facsimile: (301) 435–
4013; Email: chatterjeesa@od.nih.gov.
ADDRESSES:
Cancer
immunotherapy is a recent approach
where tumor associated antigens
(TAAs), which are primarily expressed
in human tumor cells, and not
expressed or minimally expressed in
normal tissues, are employed to
generate a tumor-specific immune
response. Specifically, these antigens
serve as targets for the host immune
system and elicit responses that results
in tumor destruction. The initiation of
an effective T-cell immune response to
antigens requires two signals. The first
one is antigen-specific via the peptide/
major histocompatibility complex and
the second or ‘‘co-stimulatory’’ signal is
required for cytokine production,
SUPPLEMENTARY INFORMATION:
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proliferation, and other aspects of T-cell
activation.
Dr. Jeffrey Schlom et al. at NCI have
identified 7 new agonist epitopes of the
MUC–1 tumor associated antigen.
Compared to their native epitope
counterparts, peptides reflecting these
agonist epitopes have enhanced ability
to generate cytotoxic T-lymphocytes
(CTL), which in turn have a greater
ability to kill MUC–1 expressing human
tumor cells. The agonist epitopes span
both the VNTR region of MUC–1 and
the C-terminus region. The epitopes
encompass two major MHC alleles
reflecting the majority of the population.
Along with the method of use, the
technology encompasses the use of
these agonist epitopes in peptide- and
protein-based vaccines, with dendritic
cells or other antigen presenting cells, or
encoding sequences in DNA, viral,
bacterial, yeast, or other types of
vectors, or to stimulate T-cells in vitro
for adoptive immunotherapy protocols.
The MUC–1 tumor associated antigen
has been shown to be overexpressed
and/or underglycosylated in a wide
range of human cancers. The C-terminus
region of MUC–1 (MUC–1C) has been
shown to be an oncogene and has been
associated with a more aggressive
phenotype in several different cancers.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR Part 404.7. The
prospective exclusive license may be
granted unless within thirty (30) days
from the date of this published notice,
the NIH receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR Part 404.7.
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]]>Agencies
[Federal Register Volume 78, Number 34 (Wednesday, February 20, 2013)]
[Notices]
[Pages 11892-11895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03836]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0961]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Environmental Impact
Considerations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).
DATES: Fax written comments on the collection of information by March
22, 2013.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0322.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Environmental Impact Considerations--(OMB Control Number 0910-0322)--
Revision
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. 4321-4327)
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.
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 (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 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 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.
In the Federal Register of September 28, 2012 (77 FR 59619), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments that were PRA related were
received from one commenter.
(Comment 1) The commenter indicated that FDA underestimates the
hours required to complete an environmental assessment for tobacco
products, and that FDA's 12 hours burden estimate per response is
substantially underestimated. The commenter said, based on the
commenter's experience, an environmental assessment for tobacco
products should take approximately 80 hours to complete.
(Response 1) FDA agrees with this comment. Upon further review of
the number of hours required to complete an environmental assessment
for tobacco products, FDA has determined that 12 hours is too low an
estimate and has revised the burden estimate per response for
completing an environmental assessment for tobacco products from 12 to
80 hours. This revision was based upon revisiting this estimate with
the Center for Tobacco Products staff and this comment. Rethinking the
time to prepare an environmental assessment for tobacco products
resulted in revising the burden per response to 80 hours.
(Comment 2) The commenter also encouraged the Agency to establish
categorical exclusions for environmental assessments for tobacco
product submittals under section 905(j) of the
[[Page 11893]]
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
387e(j)).
(Response 2) FDA has decided to not establish categorical
exclusions for tobacco products at this time.
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)(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 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 will receive approximately 15,699
claims for categorical exclusions as required under Sec. 25.15(a) and
(d), and 10 EAs as required under Sec. 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 Sec. 25.30 or Sec. 25.32 or an EA
under Sec. 25.40. In 2011, FDA received 97 industry submissions. FDA
received an annual average of 42 claims of categorical exclusions as
required under Sec. 25.15(a) and (d), and 33 EAs as required under
Sec. 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
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 Sec. 25.30 or Sec. 25.34 or an EA under Sec. 25.40. In 2011,
FDA received approximately 52 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). 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.
[[Page 11894]]
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 (Sec. 312.23), NDAs
(Sec. 314.50), ANDAs (Sec. 314.94), and PMAs (Sec. 814.20), must
contain either a claim of categorical exclusion under Sec. 25.30 or
Sec. 25.32 or an EA under Sec. 25.40. In 2011, FDA received 14 BLAs
from 14 applicants, and 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 Sec. 25.15(a) and (d), and 2
EAs as required under Sec. 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 Sec.
25.30 or Sec. 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 Sec. 25.15(a) and (d), and 10
EAs as required under Sec. 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.
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 FD&C Act (21 U.S.C. 387j
and 387k), 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
Sec. 25.30 or Sec. 25.34 or an EA under Sec. 25.40. When estimating
the burden for tobacco products, FDA considered the environmental
impacts associated with different applications. Specifically, 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 exemptions from SE
requirements applications from 500 respondents, and 3 modified risk
tobacco product applications from 3 respondents. FDA is also not
accepting claims for categorical exclusions at this time, and estimates
that there will be 135 EAs from 135 respondents as required under Sec.
25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that
approximately 135 respondents will submit an average of 1 application
for environmental assessment. Part of the information in the EA will be
developed while writing other parts of a PMTA, SE., exemption from SE,
or modified risk tobacco product application. Based on FDA's
experience, previous information provided by potential sponsors,
information provided by a commenter to this collection of information,
and knowledge that part of the EA information has already been produced
in one of the tobacco product applications, FDA estimates that it takes
approximately 80 hours to prepare an EA.
[[Page 11895]]
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
----------------------------------------------------------------------------------------------------------------
25.40(a) and (c)................ 135 1 135 80 10,800
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 10,800
----------------------------------------------------------------------------------------------------------------
\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
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................ 3,586 .............. 13,998 .............. 108,300
25.40(a) and (c)................ 190 .............. 190 .............. 80,130
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 188,430
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: February 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03836 Filed 2-19-13; 8:45 am]
BILLING CODE 4160-01-P
