Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations, 15729-15732 [2016-06711]
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Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices
Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4552,
Silver Spring, MD 20993–0002, 301–
796–8774, anahita.loloeimarsal@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
I. Statutory Background
Under section 513 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must
classify devices into one of three
regulatory classes: Class I, class II, or
class III. FDA classification of a device
is determined by the amount of
regulation necessary to provide a
reasonable assurance of safety and
effectiveness. Under the Medical Device
Amendments of 1976 (1976
amendments) (Pub. L. 94–295), as
amended by the Safe Medical Devices
Act of 1990 (Pub. L. 101–629), devices
are to be classified into class I (general
controls) if there is information showing
that the general controls of the FD&C
Act are sufficient to assure safety and
effectiveness; into class II (special
controls) if general controls, by
themselves, are insufficient to provide
reasonable assurance of safety and
effectiveness, but there is sufficient
information to establish special controls
to provide such assurance; and into
class III (premarket approval) if there is
insufficient information to support
classifying a device into class I or class
II and the device is a life sustaining or
life supporting device, or is for a use
which is of substantial importance in
preventing impairment of human health
or presents a potential unreasonable risk
of illness or injury.
Most generic types of devices that
were on the market before the date of
the 1976 amendments (May 28, 1976)
(generally referred to as preamendments
devices) have been classified by FDA
under the procedures set forth in section
513(c) and (d) of the FD&C Act through
the issuance of classification regulations
into one of these three regulatory
classes. Devices introduced into
interstate commerce for the first time on
or after May 28, 1976 (generally referred
to as postamendments devices), are
classified through the premarket
notification process under section
510(k) of the FD&C Act (21 U.S.C.
360(k)). Section 510(k) of the FD&C Act
and the implementing regulations, 21
CFR part 807, require persons who
intend to market a new device to submit
a premarket notification (510(k))
containing information that allows FDA
to determine whether the new device is
‘‘substantially equivalent’’ within the
meaning of section 513(i) of the FD&C
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Act to a legally marketed device that
does not require premarket approval.
On November 21, 1997, the President
signed into law FDAMA (Pub. L. 105–
115). Section 206 of FDAMA, in part,
added a new section, 510(m), to the
FD&C Act. Section 510(m)(1) of the
FD&C Act requires FDA, within 60 days
after enactment of FDAMA, to publish
in the Federal Register a list of each
type of class II device that does not
require a report under section 510(k) of
the FD&C Act to provide reasonable
assurance of safety and effectiveness.
Section 510(m) of the FD&C Act further
provides that a 510(k) will no longer be
required for these devices upon the date
of publication of the list in the Federal
Register. FDA published that list in the
Federal Register of January 21, 1998 (63
FR 3142).
Section 510(m)(2) of the FD&C Act
provides that 1 day after date of
publication of the list under section
510(m)(1), FDA may exempt a device on
its own initiative or upon petition of an
interested person if FDA determines
that a 510(k) is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. This section
requires FDA to publish in the Federal
Register a notice of intent to exempt a
device, or of the petition, and to provide
a 30-day comment period. Within 120
days of publication of this document,
FDA must publish in the Federal
Register its final determination
regarding the exemption of the device
that was the subject of the notice. If FDA
fails to respond to a petition under this
section within 180 days of receiving it,
the petition shall be deemed granted.
There are a number of factors FDA
may consider to determine whether a
510(k) is necessary to provide
reasonable assurance of the safety and
effectiveness of a class II device. These
factors are discussed in the guidance the
Agency issued on February 19, 1998,
entitled ‘‘Procedures for Class II Device
Exemptions from Premarket
Notification, Guidance for Industry and
CDRH Staff’’ (Ref. 1).
III. Proposed Class II Device
Exemptions
FDA has received the following
petition requesting an exemption from
premarket notification for a class II
device: Evelyn Mirza, Biorex Labs, LLC,
194 E. Wallings Rd., Suite 201,
Broadview Heights, OH 44147 for its
method, metallic reduction, glucose
(urinary, non-quantitative) test system
in a reagent tablet format classified
under 21 CFR 862.1340.
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IV. Reference
The following reference is on display
in the Division of Dockets Management
(see ADDRESSES) and is available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; it is also available electronically
at https://www.regulations.gov. FDA has
verified the Web site address, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
1. ‘‘Procedures for Class II Device
Exemptions from Premarket Notification,
Guidance for Industry and CDRH Staff,’’
February 1998, available at https://
www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM080199.pdf.
Dated: March 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–06709 Filed 3–23–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0961]
Agency Information Collection
Activities; Proposed Collection;
Submission for Office of Management
and Budget Review; Comment
Request; Environmental Impact
Considerations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
II. Criteria for Exemption
15729
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 April 25,
2016.
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.
SUMMARY:
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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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Environmental Impact
Considerations—21 CFR Part 25
OMB Control Number 0910–0322—
Extension
FDA is requesting OMB approval for
the reporting requirements contained in
the FDA collection of information
‘‘Environmental Impact
Considerations.’’ The National
Environmental Policy Act (NEPA) (42
U.S.C. 4321–4347) states national
environmental objectives and imposes
upon each Federal Agency the duty to
consider the environmental effects of its
actions. Section 102(2)(C) of NEPA
requires the preparation of an
environmental impact statement (EIS)
for every major Federal action that will
significantly affect the quality of the
human environment.
FDA’s NEPA regulations are in part 25
(21 CFR part 25). All applications or
petitions requesting Agency action
require the submission of a claim for
categorical exclusion or an
environmental assessment (EA). A
categorical exclusion applies to certain
classes of FDA-regulated actions that
usually have little or no potential to
cause significant environmental effects
and are excluded from the requirements
to prepare an EA or EIS. Section
25.15(a) and (d) specifies the procedures
for submitting to FDA a claim for a
categorical exclusion. Extraordinary
circumstances (§ 25.21), which may
result in significant environmental
impacts, may exist for some actions that
are usually categorically excluded. An
EA provides information that is used to
determine whether an FDA action could
result in a significant environmental
impact. Section 25.40(a) and (c)
specifies the content requirements for
EAs for 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.
In the Federal Register of September
8, 2015 (80 FR 53807), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
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 §§ 312.23(a)(7)(iv)(c),
314.50(d)(1)(iii), and 314.94(a)(9)(i) (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 2,501
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; 1,475 ANDAs from 300
applicants; and 5,448 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
Average
burden per
response
Total annual
responses
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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
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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
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§ 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
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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
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) ...................................................................
25.40(a) and (c) ...................................................................
42
33
1
1
42
33
8
210
336
6,930
........................
........................
........................
........................
7,266
Total ..............................................................................
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 § 814.20(b)(11) (21 CFR
814.20(b)(11)), premarket approvals
(PMAs) (original PMAs and
supplements) must contain a claim for
categorical exclusion under § 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 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
respondents
21 CFR section
25.15(a) and (d) ...................................................................
1 There
Number of
responses per
respondent
39
Average
burden per
response
Total annual
responses
1
39
Total hours
6
234
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 PRODUCTS 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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)
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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. Annually, FDA’s Center for
Veterinary Medicine has received
approximately 698 claims for categorical
exclusion as required under § 25.15(a)
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Frm 00055
Fmt 4703
Sfmt 4703
and (d), and 10 EAs as required under
§ 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
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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
Average
burden per
response
Total annual
responses
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, Drug, and Cosmetic
Act (21 U.S.C. 387e, 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
reviews 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 exemptions 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: March 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–06711 Filed 3–23–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–0406
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
SUMMARY:
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17:44 Mar 23, 2016
Jkt 238001
Management and Budget (OMB) for
review and approval. The ICR is for
renewal of the approved information
collection assigned OMB control
number 0990–0406, scheduled to expire
on April 30, 2016. Comments submitted
during the first public review of this ICR
will be provided to OMB. OMB will
accept further comments from the
public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before April 25, 2016.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the OMB
control number 0990–0406 for
reference.
Information Collection Request Title:
Evaluation of the National Partnership
for Action to End Health Disparities
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Abstract: Office of Minority Health
(OMH) in the Office of the Assistant
Secretary for Health (OASH), Office of
the Secretary (OS) is requesting
approval for an extension from the
Office of Management and Budget
(OMB) for a previously approved data
collection activity for the Evaluation of
the National Partnership for Action to
End Health Disparities (NPA). The NPA
was officially launched in April 2011 to
mobilize a nationwide, comprehensive,
community-driven, and sustained
approach to combating health
disparities and to move the nation
toward achieving health equity. Using
an approach that vests those at the front
line with the responsibility of
identifying and helping to shape core
actions, new approaches and new
partnerships are being established to
help close the health gap in the United
States.
OMH proposes to continue to conduct
the evaluation of the NPA. The
evaluation’s goal is to determine the
extent to which the NPA has
contributed to the elimination of health
disparities and attainment of health
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]]>Agencies
[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Notices]
[Pages 15729-15732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06711]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0961]
Agency Information Collection Activities; Proposed Collection;
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 April
25, 2016.
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.
[[Page 15730]]
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: 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--21 CFR Part 25
OMB Control Number 0910-0322--Extension
FDA is requesting OMB approval for the reporting requirements
contained in the FDA collection of information ``Environmental Impact
Considerations.'' The National Environmental Policy Act (NEPA) (42
U.S.C. 4321-4347) states national environmental objectives and imposes
upon each Federal Agency the duty to consider the environmental effects
of its actions. Section 102(2)(C) of 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 a significant environmental impact. Section 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.
In the Federal Register of September 8, 2015 (80 FR 53807), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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 Sec. Sec. 312.23(a)(7)(iv)(c), 314.50(d)(1)(iii), and
314.94(a)(9)(i) (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 2,501 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; 1,475 ANDAs from 300 applicants; and 5,448
supplements to ANDAs from 318 applicants. FDA estimates that it
receives approximately 13,663 claims for categorical exclusions as
required under Sec. 25.15(a) and (d), and 11 EAs as required under
Sec. 25.40(a) and (c). Based on information provided by the
pharmaceutical industry, FDA estimates that it takes sponsors or
applicants approximately 8 hours to prepare a claim for a categorical
exclusion and approximately 3,400 hours to prepare an EA.
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)................ 3,416 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. 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
[[Page 15731]]
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
------------------------------------------------------------------------------------
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 Sec. 814.20(b)(11) (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. 25.15(a) and (d), and 0 EAs as required under
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 Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses 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
Sec. 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. 25.15(a) and (d) annually and 2 EAs as required
under 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 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 Sec. 25.40. Annually, 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). 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
[[Page 15732]]
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 Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 387e, 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 reviews
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 exemptions 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: March 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06711 Filed 3-23-16; 8:45 am]
BILLING CODE 4164-01-P
