Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations, 53807-53810 [2015-22507]
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53807
Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
Instrument
Legal Service Provider List for UC ...............................................................
URM Application ...........................................................................................
Withdrawal of Application or Declination of Placement Form ......................
Standard Shelter Tour Request ....................................................................
Estimated Total Annual Burden
Hours: 172,636.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–22495 Filed 9–4–15; 8:45 am]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
Number of
responses per
respondent
58,000
350
10
60
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.
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.’’
SUMMARY:
Submit either electronic or
written comments on the collection of
information by November 9, 2015.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
DATES:
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
SUPPLEMENTARY INFORMATION:
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Frm 00049
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1
1
1
1
Average
burden hours
per response
Total burden
hours
.1 ......................
1 .......................
.1/hour ..............
.1/hour ..............
5,800
350
1
6
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 listed below.
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
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 NEPA
requires the preparation of an
E:\FR\FM\08SEN1.SGM
08SEN1
53808
Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
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. Sections
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 non-excluded 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)(c),
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. Annually, FDA receives
approximately 3,677 INDs from 2501
sponsors; 120 NDAs from 87 applicants;
2,718 supplements to NDAs from 399
applicants; 9 biologic license
applications (BLAs) from 8 applicants;
317 supplements to BLAs from 43
applicants; 1475 ANDAs from 300
applicants; and 5448 supplements to
ANDAs from 318 applicants. FDA
estimates that it receives approximately
13,663 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.
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) ...................................................................
3,416
11
4
1
13,664
11
8
3,400
109,312
37,400
Total ..............................................................................
........................
........................
........................
........................
146,712
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
asabaliauskas on DSK5VPTVN1PROD 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.
Annually, FDA receives approximately
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). 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 8 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) ...................................................................
25.40(a) and (c) ...................................................................
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Frm 00050
Number of
responses per
respondent
42
33
Fmt 4703
Sfmt 4703
Total annual
responses
1
1
E:\FR\FM\08SEN1.SGM
42
33
08SEN1
Average
burden per
response
8
210
Total hours
336
6,930
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Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN FOODS 1—Continued
Number of
respondents
21 CFR section
Total ..............................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
7,266
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 (PMAs) (original
PMAs and supplements) must contain a
claim for categorical exclusion under
approximately 39 respondents will
submit an average of 1 application for
categorical exclusion annually. Based
on information provided by 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 2012 to 2014, FDA received
an average of 39 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). FDA estimates that
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) ...................................................................
39
1
39
6
234
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
Under 21 CFR 601.2(a), BLAs 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. Annually,
FDA receives approximately 34 BLAs
from 18 applicants, 801 BLA
supplements to license applications
from 156 applicants, 345 INDs from 256
sponsors, 1 NDA from 1 applicant, 26
supplements to NDAs from 8 applicants,
1 ANDA from 1 applicant, 1 supplement
to ANDAs from 1 applicant, 8 PMAs
from 3 applicants, and 33 PMA
supplements from 16 applicants. FDA
estimates that approximately 10 percent
of these supplements would be
submitted with a claim for categorical
exclusion or an EA.
FDA has received approximately 481
claims for categorical exclusion as
required under §§ 25.15(a) and (d)
annually and 2 EAs as required under
§§ 25.40(a) and (c) annually. Therefore,
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 PRODUCTS1
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.
asabaliauskas on DSK5VPTVN1PROD 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
VerDate Sep<11>2014
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Jkt 235001
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. Annually, 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). FDA estimates that
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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. 80, No. 173 / Tuesday, September 8, 2015 / 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 (21 U.S.C. 387, 387j, and 387k),
product applications and supplements
(PMTAs), SEs, Exemption from SEs, and
modified risk tobacco products must
contain a claim for categorical exclusion
or an EA. In 2015, FDA estimated it will
receive approximately 5 premarket
review of new tobacco PMTAs from 5
respondents, 509 reports intended to
demonstrate the substantial equivalence
of a new tobacco product (SEs) from 509
respondents, 15 exemption from
substantial equivalence requirements
applications (SE Exemptions) from 15
respondents, and 3 modified risk
tobacco product applications (MRTPAs)
from 3 respondents. FDA is not
accepting claims for categorical
exclusions at this time, and estimates
that there will be 532 EAs from 532
respondents as required under
§§ 25.40(a) and (c). Therefore, over the
next 3 years, FDA estimates that
approximately 532 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 MRTPA.
Based on FDA’s experience, previous
information provided by potential
sponsors 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.
TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.40(a) and (c) ...................................................................
532
1
532
80
42,560
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
substantial equivalence (SE) of a new
tobacco product, including
demonstrating SE when the new tobacco
product has: A modified label that
renders it distinct from, but has
identical characteristics to, a valid
predicate product; or a change in
product quantity from, but where the
per weight composition is identical to,
a valid predicate product.
[FR Doc. 2015–22507 Filed 9–4–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Submit either electronic or
written comments on Agency guidances
at any time.
DATES:
[Docket No. FDA–2011–D–0147]
Demonstrating the Substantial
Equivalence of a New Tobacco
Product: Responses to Frequently
Asked Questions; Second Edition;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
second edition of the guidance for
industry entitled ‘‘Demonstrating the
Substantial Equivalence of a New
Tobacco Product: Responses to
Frequently Asked Questions’’. FDA is
issuing the second edition to provide
further information on demonstrating
SUMMARY:
VerDate Sep<11>2014
17:18 Sep 04, 2015
Jkt 235001
All communications in
response to this notice should be
identified with Docket No. FDA–2011–
D–0147. Submit electronic comments on
the guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Annette Marthaler, Center for Tobacco
Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002; 1–877–287–1373,
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
CTPRegulations@fda.hhs.gov, or
annette.marthaler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
the second edition of the guidance for
industry entitled ‘‘Demonstrating the
Substantial Equivalence of a New
Tobacco Product: Responses to
Frequently Asked Questions’’ (second
edition SE FAQ guidance). We are
issuing this guidance consistent with
our good guidance practices regulation
(21 CFR 10.115).
In September 2011, FDA issued draft
guidance responding to frequently asked
questions covering a range of topics on
demonstrating the SE of a new tobacco
product (September 9, 2011, 76 FR
55927). In March 2015, FDA issued a
final guidance on many of the topics
included in the September 2011 draft
((March 5, 2015, 80 FR 12011) (March
2015 FAQ guidance)). In May 2015,
FDA announced that an interim
enforcement policy would be in effect
while it considered comments
submitted on the March 2015 FAQ
guidance. This interim enforcement
policy will continue to be in effect for
30 days from the date of issuance of the
E:\FR\FM\08SEN1.SGM
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Agencies
[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Notices]
[Pages 53807-53810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22507]
-----------------------------------------------------------------------
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 9, 2015.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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 listed below.
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
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 NEPA requires the preparation of
an
[[Page 53808]]
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. Sections 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 non-excluded 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)(c), 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. Annually, FDA receives
approximately 3,677 INDs from 2501 sponsors; 120 NDAs from 87
applicants; 2,718 supplements to NDAs from 399 applicants; 9 biologic
license applications (BLAs) from 8 applicants; 317 supplements to BLAs
from 43 applicants; 1475 ANDAs from 300 applicants; and 5448
supplements to ANDAs from 318 applicants. FDA estimates that it
receives approximately 13,663 claims for categorical exclusions as
required under Sec. Sec. 25.15(a) and (d), and 11 EAs as required
under Sec. 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.
Table 1--Estimated Annual Reporting Burden for Human Drugs \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)................ 3,416 4 13,664 8 109,312
25.40(a) and (c)................ 11 1 11 3,400 37,400
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 146,712
----------------------------------------------------------------------------------------------------------------
\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. Annually, FDA receives approximately 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. Sec. 25.40(a) and (c). 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 8 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
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................ 42 1 42 8 336
25.40(a) and (c)................ 33 1 33 210 6,930
=================
[[Page 53809]]
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 (PMAs) (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 2012 to
2014, FDA received an average of 39 claims (original PMAs and
supplements) for categorical exclusions as required under Sec. Sec.
25.15(a) and (d), and 0 EAs as required under Sec. Sec. 25.40(a) and
(c). FDA estimates that approximately 39 respondents will submit an
average of 1 application for categorical exclusion annually. Based on
information provided by 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).................................... 39 1 39 6 234
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
Under 21 CFR 601.2(a), BLAs 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
25.32 or an EA under Sec. 25.40. Annually, FDA receives approximately
34 BLAs from 18 applicants, 801 BLA supplements to license applications
from 156 applicants, 345 INDs from 256 sponsors, 1 NDA from 1
applicant, 26 supplements to NDAs from 8 applicants, 1 ANDA from 1
applicant, 1 supplement to ANDAs from 1 applicant, 8 PMAs from 3
applicants, and 33 PMA supplements from 16 applicants. FDA estimates
that approximately 10 percent of these supplements would be submitted
with a claim for categorical exclusion or an EA.
FDA has received approximately 481 claims for categorical exclusion
as required under Sec. Sec. 25.15(a) and (d) annually and 2 EAs as
required under Sec. Sec. 25.40(a) and (c) annually. Therefore, 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
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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 25.33 or an EA under Sec. 25.40. Annually, FDA's Center for
Veterinary Medicine has received approximately 698 claims for
categorical exclusion as required under Sec. Sec. 25.15(a) and (d),
and 10 EAs as required under Sec. Sec. 25.40(a) and (c). 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 53810]]
Table 5--Estimated Annual Reporting Burden for Animal Drugs \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)................ 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 (21 U.S.C. 387, 387j, and 387k), product applications and
supplements (PMTAs), SEs, Exemption from SEs, and modified risk tobacco
products must contain a claim for categorical exclusion or an EA. In
2015, FDA estimated it will receive approximately 5 premarket review of
new tobacco PMTAs from 5 respondents, 509 reports intended to
demonstrate the substantial equivalence of a new tobacco product (SEs)
from 509 respondents, 15 exemption from substantial equivalence
requirements applications (SE Exemptions) from 15 respondents, and 3
modified risk tobacco product applications (MRTPAs) from 3 respondents.
FDA is not accepting claims for categorical exclusions at this time,
and estimates that there will be 532 EAs from 532 respondents as
required under Sec. Sec. 25.40(a) and (c). Therefore, over the next 3
years, FDA estimates that approximately 532 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 MRTPA. Based on FDA's experience,
previous information provided by potential sponsors 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.
Table 6--Estimated Annual Reporting Burden for Tobacco Products \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c)................................................... 532 1 532 80 42,560
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22507 Filed 9-4-15; 8:45 am]
BILLING CODE 4164-01-P