80 FR 53807 - Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 173 (September 8, 2015)

Page Range		53807-53810
FR Document		2015-22507

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.''

Federal Register, Volume 80 Issue 173 (Tuesday, September 8, 2015)

[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Notices]
[Pages 53807-53810]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-22507]

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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: http://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

Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices 53807

ANNUAL BURDEN ESTIMATES—Continued
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Legal Service Provider List for UC ............................................................... 58,000 1 .1 ...................... 5,800
URM Application ........................................................................................... 350 1 1 ....................... 350
Withdrawal of Application or Declination of Placement Form ...................... 10 1 .1/hour .............. 1
Standard Shelter Tour Request .................................................................... 60 1 .1/hour .............. 6

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Office of Management and Budget
Hours: 172,636. HUMAN SERVICES (OMB) for each collection of
In compliance with the requirements information they conduct or sponsor.
Food and Drug Administration ‘‘Collection of information’’ is defined
of Section 506(c)(2)(A) of the Paperwork
in 44 U.S.C. 3502(3) and 5 CFR
Reduction Act of 1995, the [Docket No. FDA–2012–N–0961]
1320.3(c) and includes Agency requests
Administration for Children and
Agency Information Collection or requirements that members of the
Families is soliciting public comment public submit reports, keep records, or
on the specific aspects of the Activities; Proposed Collection;
Comment Request; Environmental provide information to a third party.
information collection described above. Section 3506(c)(2)(A) of the PRA (44
Impact Considerations
Copies of the proposed collection of U.S.C. 3506(c)(2)(A)) requires Federal
information can be obtained and AGENCY: Food and Drug Administration, Agencies to provide a 60-day notice in
comments may be forwarded by writing HHS. the Federal Register concerning each
to the Administration for Children and ACTION: Notice. proposed collection of information,
Families, Office of Planning, Research including each proposed extension of an
and Evaluation, 370 L’Enfant SUMMARY: The Food and Drug existing collection of information,
Promenade SW., Washington, DC 20447, Administration (FDA) is announcing an before submitting the collection to OMB
Attn: ACF Reports Clearance Officer. opportunity for public comment on the for approval. To comply with this
Email address: infocollection@ proposed collection of certain requirement, FDA is publishing notice
acf.hhs.gov. All requests should be information by the Agency. Under the of the proposed collection of
identified by the title of the information Paperwork Reduction Act of 1995 (the information listed below.
collection. PRA), Federal Agencies are required to With respect to the following
publish notice in the Federal Register collection of information, FDA invites
The Department specifically requests concerning each proposed collection of comments on these topics: (1) Whether
comments on: (a) Whether the proposed information, including each proposed the proposed collection of information
collection of information is necessary extension of an existing collection of is necessary for the proper performance
for the proper performance of the information, and to allow 60 days for of FDA’s functions, including whether
functions of the agency, including public comment in response to the the information will have practical
whether the information shall have notice. This notice solicits comments on utility; (2) the accuracy of FDA’s
practical utility; (b) the accuracy of the the information collection entitled estimate of the burden of the proposed
agency’s estimate of the burden of the ‘‘Environmental Impact collection of information, including the
proposed collection of information; (c) Considerations.’’ validity of the methodology and
the quality, utility, and clarity of the assumptions used; (3) ways to enhance
DATES: Submit either electronic or
information to be collected; and (d) the quality, utility, and clarity of the
written comments on the collection of
ways to minimize the burden of the information to be collected; and (4)
information by November 9, 2015.
collection of information on ways to minimize the burden of the
ADDRESSES: Submit electronic collection of information on
respondents, including through the use comments on the collection of
of automated collection techniques or respondents, including through the use
information to: http:// of automated collection techniques,
other forms of information technology. www.regulations.gov. Submit written
Consideration will be given to when appropriate, and other forms of
comments on the collection of information technology.
comments and suggestions submitted information to the Division of Dockets
within 60 days of this publication. Management (HFA 305), Food and Drug Environmental Impact
Administration, 5630 Fishers Lane, Rm. Considerations—21 CFR Part 25
Robert Sargis,
1061, Rockville, MD 20852. All OMB Control Number 0910–0322
Reports Clearance Officer. comments should be identified with the
[FR Doc. 2015–22495 Filed 9–4–15; 8:45 am] docket number found in brackets in the FDA is requesting OMB approval for
BILLING CODE 4184–01–P heading of this document. the reporting requirements contained in
the FDA collection of information
FOR FURTHER INFORMATION CONTACT: FDA
‘‘Environmental Impact
asabaliauskas on DSK5VPTVN1PROD with NOTICES

PRA Staff, Office of Operations, Food Considerations.’’ The National
and Drug Administration, 8455 Environmental Policy Act (NEPA) (42
Colesville Rd., COLE–14526, Silver U.S.C. 4321–4347) states national
Spring, MD 20993–0002, PRAStaff@ environmental objectives and imposes
fda.hhs.gov. upon each Federal Agency the duty to
SUPPLEMENTARY INFORMATION: Under the consider the environmental effects of its
PRA (44 U.S.C. 3501–3520), Federal actions. Section 102(2)(C) of NEPA
Agencies must obtain approval from the requires the preparation of an

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53808 Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices

environmental impact statement (EIS) is responsible must, in most instances, Estimated Annual Reporting Burden for
for every major Federal action that will submit applications requesting Human Drugs (Including Biologics in
significantly affect the quality of the approval. Environmental information the Center for Drug Evaluation and
human environment. must be included in such applications Research)
FDA’s NEPA regulations are in part 25 for the purpose of determining whether
(21 CFR part 25). All applications or the proposed action may have a Under 21 CFR 312.23(a)(7)(iv)(c),
petitions requesting Agency action significant impact on the environment. 314.50(d)(1)(iii), and 314.94(a)(9)(i),
require the submission of a claim for Where significant adverse events cannot each investigational new drug
categorical exclusion or an be avoided, the Agency uses the application (IND), new drug application
environmental assessment (EA). A submitted information as the basis for (NDA), and abbreviated new drug
categorical exclusion applies to certain preparing and circulating to the public application (ANDA) must contain a
classes of FDA-regulated actions that an EIS, made available through a claim for categorical exclusion under
usually have little or no potential to Federal Register document also filed for § 25.30 or § 25.31, or an EA under
cause significant environmental effects comment at the Environmental § 25.40. Annually, FDA receives
and are excluded from the requirements Protection Agency. The final EIS, approximately 3,677 INDs from 2501
to prepare an EA or EIS. Sections including the comments received, is sponsors; 120 NDAs from 87 applicants;
25.15(a) and (d) specifies the procedures reviewed by the Agency to weigh 2,718 supplements to NDAs from 399
for submitting to FDA a claim for a environmental costs and benefits in applicants; 9 biologic license
categorical exclusion. Extraordinary determining whether to pursue the applications (BLAs) from 8 applicants;
circumstances (§ 25.21), which may proposed action or some alternative that 317 supplements to BLAs from 43
result in significant environmental would reduce expected environmental applicants; 1475 ANDAs from 300
impacts, may exist for some actions that impact.
are usually categorically excluded. An Any final EIS would contain applicants; and 5448 supplements to
EA provides information that is used to additional information gathered by the ANDAs from 318 applicants. FDA
determine whether an FDA action could Agency after the publication of the draft estimates that it receives approximately
result in a significant environmental EIS, a copy or a summary of the 13,663 claims for categorical exclusions
impact. Sections 25.40(a) and (c) comments received on the draft EIS, and as required under §§ 25.15(a) and (d),
specifies the content requirements for the Agency’s responses to the and 11 EAs as required under
EAs for non-excluded actions. comments, including any revisions §§ 25.40(a) and (c). Based on
This collection of information is used resulting from the comments or other information provided by the
by FDA to assess the environmental information. When the Agency finds pharmaceutical industry, FDA estimates
impact of Agency actions and to ensure that no significant environmental effects that it takes sponsors or applicants
that the public is informed of are expected, the Agency prepares a approximately 8 hours to prepare a
environmental analyses. Firms wishing finding of no significant impact. claim for a categorical exclusion and
to manufacture and market substances FDA estimates the burden of this approximately 3,400 hours to prepare an
regulated under statues for which FDA collection of information as follows: EA.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent 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 categorical exclusion under § 25.30 or respondents will submit an average of 1
Human Foods § 25.32 or an EA under § 25.40. application for categorical exclusion
Under 21 CFR 71.1, 171.1, 170.39, and Annually, FDA receives approximately and 33 respondents will submit an
170.100, food additive petitions, color 97 industry submissions. FDA received average of 1 EA. FDA estimates that, on
additive petitions, requests from an annual average of 42 claims of average, it takes petitioners, notifiers, or
exemption from regulation as a food categorical exclusions as required under requestors approximately 8 hours to
additive, and submission of a food § 25.15(a) and (d) and 33 EAs as prepare a claim of categorical exclusion
contact notification for a food contact required under §§ 25.40(a) and (c). FDA and approximately 210 hours to prepare
substance must contain either a claim of estimates that approximately 42 an EA.

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN FOODS 1
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

25.15(a) and (d) ................................................................... 42 1 42 8 336
25.40(a) and (c) ................................................................... 33 1 33 210 6,930

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Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices 53809

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN FOODS 1—Continued
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

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 § 25.30 or § 25.34 or an EA under approximately 39 respondents will
Medical Devices § 25.40. In 2012 to 2014, FDA received submit an average of 1 application for
an average of 39 claims (original PMAs categorical exclusion annually. Based
Under 21 CFR 814.20(b)(11), and supplements) for categorical on information provided by sponsors,
premarket approvals (PMAs) (original exclusions as required under §§ 25.15(a) FDA estimates that it takes
PMAs and supplements) must contain a and (d), and 0 EAs as required under approximately 6 hours to prepare a
claim for categorical exclusion under §§ 25.40(a) and (c). FDA estimates that claim for a categorical exclusion.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR MEDICAL DEVICES 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent 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 from 156 applicants, 345 INDs from 256 annually and 2 EAs as required under
Biological Products, Drugs, and sponsors, 1 NDA from 1 applicant, 26 §§ 25.40(a) and (c) annually. Therefore,
Medical Devices in the Center for supplements to NDAs from 8 applicants, FDA estimates that approximately 247
Biologics Evaluation and Research 1 ANDA from 1 applicant, 1 supplement respondents will submit an average of 2
to ANDAs from 1 applicant, 8 PMAs applications for categorical exclusion
Under 21 CFR 601.2(a), BLAs as well from 3 applicants, and 33 PMA and 2 respondents will submit an
as INDs (§ 312.23), NDAs (§ 314.50), supplements from 16 applicants. FDA average of 1 EA. Based on information
ANDAs (§ 314.94), and PMAs (§ 814.20) estimates that approximately 10 percent provided by industry, FDA estimates
must contain either a claim of of these supplements would be that it takes sponsors and applicants
categorical exclusion under § 25.30 or submitted with a claim for categorical
25.32 or an EA under § 25.40. Annually, approximately 8 hours to prepare a
exclusion or an EA.
FDA receives approximately 34 BLAs FDA has received approximately 481 claim of categorical exclusion and
from 18 applicants, 801 BLA claims for categorical exclusion as approximately 3,400 hours to prepare an
supplements to license applications required under §§ 25.15(a) and (d) EA for a biological product.

TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent 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 applications (INADs), and 21 CFR approximately 70 respondents will
Animal Drugs 571.1(c) food additive petitions must submit an average of 10 applications for
contain a claim for categorical exclusion categorical exclusion and 10
Under 21 CFR 514.1(b)(14), new under § 25.30 or 25.33 or an EA under respondents will submit an average of 1
animal drug applications (NADAs) and § 25.40. Annually, FDA’s Center for EA. FDA estimates that it takes
abbreviated new animal drug Veterinary Medicine has received sponsors/applicants approximately 3
asabaliauskas on DSK5VPTVN1PROD with NOTICES

applications (ANADAs); 21 CFR approximately 698 claims for categorical hours to prepare a claim of categorical
514.8(a)(1) supplemental NADAs and exclusion as required under §§ 25.15(a) exclusion and an average of 2,160 hours
ANADAs; 21 CFR 511.1(b)(10) and (d), and 10 EAs as required under to prepare an EA.
investigational new animal drug §§ 25.40(a) and (c). FDA estimates that

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53810 Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent 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 demonstrate the substantial equivalence approximately 532 respondents will
Tobacco Products of a new tobacco product (SEs) from 509 submit an average of 1 application for
respondents, 15 exemption from environmental assessment. Part of the
Under sections 905, 910, and 911 of substantial equivalence requirements information in the EA will be developed
the Federal Food, Drugs, and Cosmetic applications (SE Exemptions) from 15 while writing other parts of a PMTA,
Act (21 U.S.C. 387, 387j, and 387k), respondents, and 3 modified risk SE, Exemption from SE, or MRTPA.
product applications and supplements tobacco product applications (MRTPAs) Based on FDA’s experience, previous
(PMTAs), SEs, Exemption from SEs, and from 3 respondents. FDA is not information provided by potential
modified risk tobacco products must accepting claims for categorical sponsors and knowledge that part of the
contain a claim for categorical exclusion exclusions at this time, and estimates EA information has already been
or an EA. In 2015, FDA estimated it will that there will be 532 EAs from 532 produced in one of the tobacco product
receive approximately 5 premarket respondents as required under applications, FDA estimates that it takes
review of new tobacco PMTAs from 5 §§ 25.40(a) and (c). Therefore, over the approximately 80 hours to prepare an
respondents, 509 reports intended to next 3 years, FDA estimates that EA.

TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent 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. substantial equivalence (SE) of a new CTPRegulations@fda.hhs.gov, or
Leslie Kux, tobacco product, including annette.marthaler@fda.hhs.gov.
Associate Commissioner for Policy. demonstrating SE when the new tobacco SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–22507 Filed 9–4–15; 8:45 am] product has: A modified label that
renders it distinct from, but has I. Background
BILLING CODE 4164–01–P
identical characteristics to, a valid We are announcing the availability of
predicate product; or a change in the second edition of the guidance for
DEPARTMENT OF HEALTH AND product quantity from, but where the industry entitled ‘‘Demonstrating the
HUMAN SERVICES per weight composition is identical to, Substantial Equivalence of a New
a valid predicate product. Tobacco Product: Responses to
Food and Drug Administration Frequently Asked Questions’’ (second
DATES: Submit either electronic or edition SE FAQ guidance). We are
[Docket No. FDA–2011–D–0147] written comments on Agency guidances issuing this guidance consistent with
at any time. our good guidance practices regulation
Demonstrating the Substantial
Equivalence of a New Tobacco ADDRESSES: All communications in (21 CFR 10.115).
response to this notice should be In September 2011, FDA issued draft
Product: Responses to Frequently
identified with Docket No. FDA–2011– guidance responding to frequently asked
Asked Questions; Second Edition;
D–0147. Submit electronic comments on questions covering a range of topics on
Guidance for Industry; Availability
the guidance to http:// demonstrating the SE of a new tobacco
AGENCY: Food and Drug Administration, www.regulations.gov. Submit written product (September 9, 2011, 76 FR
HHS. comments to the Division of Dockets 55927). In March 2015, FDA issued a
ACTION: Notice. Management (HFA–305), Food and Drug final guidance on many of the topics
Administration, 5630 Fishers Lane, Rm. included in the September 2011 draft
SUMMARY: The Food and Drug ((March 5, 2015, 80 FR 12011) (March
asabaliauskas on DSK5VPTVN1PROD with NOTICES

1061, Rockville, MD 20852.
Administration (FDA) is announcing a 2015 FAQ guidance)). In May 2015,
second edition of the guidance for FOR FURTHER INFORMATION CONTACT: FDA announced that an interim
industry entitled ‘‘Demonstrating the Annette Marthaler, Center for Tobacco enforcement policy would be in effect
Substantial Equivalence of a New Products, Food and Drug while it considered comments
Tobacco Product: Responses to Administration, Document Control submitted on the March 2015 FAQ
Frequently Asked Questions’’. FDA is Center, Bldg. 71, Rm. G335, 10903 New guidance. This interim enforcement
issuing the second edition to provide Hampshire Ave., Silver Spring, MD policy will continue to be in effect for
further information on demonstrating 20993–0002; 1–877–287–1373, 30 days from the date of issuance of the

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Document Created: 2018-02-26 10:13:47
Document Modified: 2018-02-26 10:13:47

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by November 9, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 53807

80 FR 53807 - Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 173 (September 8, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration