Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations, 63179-63182 [2018-26556]
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• For written/paper comments
submitted to the Dockets Management
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information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–4000 for ‘‘Framework for a
Real-World Evidence Program;
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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Docket: For access to the docket to
read background documents or the
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received, go to https://
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Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Dianne Paraoan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326,
Silver Spring, MD 20993–0002, 301–
796–2500, dianne.paraoan@fda.hhs.gov;
or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911, stephen.ripley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is establishing a public docket to
collect comments on its ‘‘Framework for
a Real-World Evidence Program.’’
Section 3022 of the Cures Act amended
the FD&C Act to add section 505F,
Utilizing real world evidence (21 U.S.C.
355g). This section requires the
establishment of a program to evaluate
the potential use of RWE to help
support the approval of a new
indication for a drug approved under
section 505(c) of the FD&C Act (21
U.S.C. 355(c)) and to help to support or
satisfy postapproval study requirements.
This section also requires FDA publish
a framework for that program. In
addition to drug and biological products
approved under section 505(c) of the
FD&C Act, FDA is also applying this
framework to biological products
licensed under section 351 of the Public
Health Service Act (42 U.S.C. 262).
The statute directs that the framework
for the RWE program include
information describing sources of RWE,
gaps in data collection activities,
standards and methodologies for
collecting and analyzing RWE, and
priority areas, remaining challenges,
and potential pilot opportunities to
address the overarching Cures Act
requirements. To help meet a
requirement in the Cures Act for
consultation in developing the program
framework, on September 13, 2017,
through its cooperative agreement with
the Duke Margolis Center for Health
Policy, FDA convened a public meeting
that explored the use of RWE for
regulatory decisions. Representatives
from industry, academia, and patient
advocacy groups discussed, among
other things, opportunities and
challenges associated with applying
real-world data and RWE, the evidence
derived from that data, to demonstrate
product effectiveness, including data
acquisition, study design, and analytic
methods necessary to establish causal
inference. The workshop helped to
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63179
inform FDA’s RWE framework. FDA
will continue to consult stakeholders
through public-private partnerships,
public workshops, and demonstration
projects as it implements its RWE
program.
II. Electronic Access
Persons with access to the internet
may obtain the ‘‘Framework for the
Real-World Evidence Program’’ at
https://www.fda.gov/
RegulatoryInformation/LawsEnfor
cedbyFDA/SignificantAmendmentsto
theFDCAct/21stCenturyCuresAct/
ucm562475.htm.
Dated: November 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26546 Filed 12–6–18; 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; Submission for Office of
Management and Budget Review;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 7,
2019.
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:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
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20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Environmental Impact Considerations
OMB Control Number 0910–0322—
Extension
I. Background
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 statutes 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 June 7, 2018
(83 FR 26477), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
One PRA related comment was
received.
(Comment) One commenter requested
that FDA should categorically exclude
all categories of SE applications from
the EA requirement.
(Response) FDA appreciates this
comment. We note, however, that any
action to establish a categorial exclusion
would need to be undertaken through a
notice and comment rulemaking
procedure.
FDA estimates the burden of this
collection of information as follows:
II. Estimated Annual Reporting Burden
for Human Drugs (Including Biologics
in the Center for Drug Evaluation and
Research)
Under §§ 312.23(a)(7)(iv)(e),
314.50(d)(1)(iii), and 314.94(a)(9)(i) (21
CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii),
and 314.94(a)(9)(i)), each investigational
new drug application (IND), new drug
application (NDA), and abbreviated new
drug application (ANDA) must contain
a claim for categorical exclusion under
§ 25.30 or § 25.31, or an EA under
§ 25.40. Annually, FDA receives
approximately 3,687 INDs from 2,456
sponsors; 140 NDAs from 116
applicants; 3,192 supplements to NDAs
from 443 applicants; 28 biologic license
applications (BLAs) from 22 applicants;
464 supplements to BLAs from 52
applicants; 1,152 ANDAs from 248
applicants; and 6,774 supplements to
ANDAs from 384 applicants. FDA
estimates that it receives approximately
15,437 claims for categorical exclusions
as required under § 25.15(a) and (d) and
10 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
Total annual
responses
Average
burden per
response
Total hours
25.15(a) and (d) ...................................................................
25.40(a) and (c) ...................................................................
3,724
10
4.1453
1
15,437
10
8
3,400
123,496
34,000
Total ..............................................................................
........................
........................
........................
........................
157,496
1 There
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Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Estimated Annual Reporting
Burden for Medical Devices
Under § 814.20(b)(11) (21 CFR
814.20(b)(11)), premarket approvals
(PMAs) (original PMAs and
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supplements) must contain a claim for
categorical exclusion under § 25.30 or
§ 25.34 or an EA under § 25.40. In 2017,
FDA received an average of 50 claims
(original PMAs and supplements) for
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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 50 respondents will
submit an average of 1 application for
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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 2—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
50
Total annual
responses
1
Average
burden per
response
50
Total hours
6
300
are no capital costs or operating and maintenance costs associated with this collection of information.
IV. 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 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15(a) and (d) ...................................................................
25.40(a) and (c) ...................................................................
247
2
2
1
494
2
8
3,400
3,952
6,800
Total ..............................................................................
........................
........................
........................
........................
10,752
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
V. 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 generic
investigational new animal drug
applications (JINADs), and 21 CFR
571.1(c) food additive petitions must
contain a claim for categorical exclusion
under § 25.30 or § 25.32 or an EA under
§ 25.40. Annually, FDA’s Center for
Veterinary Medicine has received
approximately 810 claims for categorical
exclusion as required under § 25.15(a)
and (d) and 22 EAs as required under
§ 25.40(a) and (c). Assuming an average
of 10 claims per respondent, FDA
estimates that approximately 81
respondents will submit an average of
10 claims for categorical exclusion. FDA
further estimates that 22 respondents
will submit an average of 1 EA. FDA
estimates that it takes sponsors/
applicants approximately 3 hours to
prepare a claim of categorical exclusion
and an average of 2,160 hours to prepare
an EA.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1
Number of
respondents
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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) ...................................................................
81
22
10
1
810
22
3
2,160
2,430
47,520
Total ..............................................................................
........................
........................
........................
........................
49,950
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VI. Estimated Annual Reporting Burden
for Tobacco Products
Under sections 905, 910, and 911 of
the Federal Food, Drug, and Cosmetic
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Act (21 U.S.C. 387e, 387j, and 387k),
product applications and supplements
(PMTAs), SEs, Exemption from SEs, and
modified risk tobacco products must
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contain a claim for categorical exclusion
or an EA. After further review, the
agency has concluded that the majority
of the EA burden for tobacco products
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is covered under already existing
information collections. To avoid
double counting, the agency has
removed the burden which is approved
under other FDA information
collections. The burden for SEs are
currently approved under OMB control
number 0910–0673; the burden for
PMTAs are currently approved under
OMB control number 0910–0768; the
burden for SE exemptions are currently
approved under OMB control number
0910–0684.
FDA’s estimates are based on actual
report data from fiscal year (FY) 2015 to
FY 2017, on average FDA estimated it
received approximately 27 modified risk
tobacco product applications (MRTPAs)
from 27 respondents. Based on updated
data for this collection, FDA estimates
27 EAs from 27 respondents. A total of
27 respondents will submit an average
of 1 application for environmental
assessment. 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 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of
respondents
21 CFR section
25.40(a) and (c) ...................................................................
1 There
27
Total annual
responses
1
27
Average
burden per
response
80
Total hours
2,160
are no capital costs or operating and maintenance costs associated with this collection of information.
The Estimated Annual Reporting
Burden for Human Foods is no longer a
part of this information collection. The
burden has now been incorporated into
OMB control number 0910–0541.
Our estimated burden for the
information collection reflects an
overall decrease of 10,566 hours
(currently approved 231,224) and a
corresponding decrease of 11,364
annual responses (currently approved
15,527). The new estimated totals are
220,658 hours and 4,163 annual
responses. We attribute this adjustment
to the removal of the majority tobacco
burden from this collection, and the
number of EA submissions we received
since the last extension.
Dated: November 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26556 Filed 12–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Family-to-Family Health
Information Center Feedback Surveys,
OMB Number: 0906–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
amozie on DSK3GDR082PROD with NOTICES
Number of
responses per
respondent
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
SUMMARY:
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16:56 Dec 06, 2018
Jkt 247001
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR must be
received no later than January 7, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Family-to-Family Health Information
Center Feedback Surveys, OMB Control
Number: 0906–xxxx–New.
Abstract: The Family-to-Family
Health Information Center (F2F HIC)
program is authorized by the Social
Security Act, Title V, § 501(c) (42 U.S.C.
701(c)), as amended by § 50501 of the
Bipartisan Budget Act of 2018 (Pub. L.
115–123). The goal of the F2F HIC
program is to promote optimal health
for children and youth with special
health care needs (CYSHCN) by
facilitating their access to an effective
health delivery system and by meeting
the health information and support
needs of families of CYSHCN and the
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professionals who serve them. F2F HICs
are staffed by families of CYSHCN who
have first-hand knowledge using health
care services and programs. With this
experience, these staff are uniquely
positioned to provide support to other
CYSHCN families and help other
families like theirs navigate an often
complex and confusing health care and
social service system. They also serve as
mentors and as a reliable source of
health care information to other
families.
During Fiscal Years (FY) 2003 to
2017, HRSA’s Maternal and Child
Health Bureau (MCHB) awarded
approximately $4.9 million per FY in
grants to support 51 F2F HICs in each
of the 50 states and the District of
Columbia. In FY 2017, 49 centers that
reported data served and trained over
184,000 families and approximately
85,500 health professionals. For FYs
2018 and 2019, HRSA MCHB will award
approximately $6 million per FY to
support 59 F2F HICs: One each in the
50 states and the District of Columbia,
1 each in the 5 U.S. Territories
(American Samoa, Guam, Puerto Rico,
the Northern Mariana Islands and the
U.S. Virgin Islands), and 3 to serve
American Indians/Alaska Natives.
HRSA has developed feedback
surveys to determine the extent to
which F2F HICs provide service to
families of CYSHCN and health
professionals who serve such families.
Each F2F HIC will administer the
surveys and report data back to HRSA.
Survey respondents will be asked to
answer questions about how useful they
found the information, assistance, or
resources received from the F2F HICs.
The purpose of this notice is to solicit
comments regarding the proposed
feedback surveys and the F2F HIC grant
recipient activity instructions form.
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]]>Agencies
[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Notices]
[Pages 63179-63182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26556]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0961]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Environmental Impact
Considerations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
7, 2019.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0322.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD
[[Page 63180]]
20852, 301-796-8867, [email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Environmental Impact Considerations
OMB Control Number 0910-0322--Extension
I. Background
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 statutes 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 June 7, 2018 (83 FR 26477), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One PRA related comment was received.
(Comment) One commenter requested that FDA should categorically
exclude all categories of SE applications from the EA requirement.
(Response) FDA appreciates this comment. We note, however, that any
action to establish a categorial exclusion would need to be undertaken
through a notice and comment rulemaking procedure.
FDA estimates the burden of this collection of information as
follows:
II. 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)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i)), each investigational new drug application (IND), new
drug application (NDA), and abbreviated new drug application (ANDA)
must contain a claim for categorical exclusion under Sec. 25.30 or
Sec. 25.31, or an EA under Sec. 25.40. Annually, FDA receives
approximately 3,687 INDs from 2,456 sponsors; 140 NDAs from 116
applicants; 3,192 supplements to NDAs from 443 applicants; 28 biologic
license applications (BLAs) from 22 applicants; 464 supplements to BLAs
from 52 applicants; 1,152 ANDAs from 248 applicants; and 6,774
supplements to ANDAs from 384 applicants. FDA estimates that it
receives approximately 15,437 claims for categorical exclusions as
required under Sec. 25.15(a) and (d) and 10 EAs as required under
Sec. 25.40(a) and (c). 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)................ 3,724 4.1453 15,437 8 123,496
25.40(a) and (c)................ 10 1 10 3,400 34,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 157,496
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
III. 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 2017, FDA received an average of 50 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 50 respondents will
submit an average of 1 application for
[[Page 63181]]
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 2--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)................ 50 1 50 6 300
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
IV. 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 3--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.
V. 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 generic investigational new animal
drug applications (JINADs), and 21 CFR 571.1(c) food additive petitions
must contain a claim for categorical exclusion under Sec. 25.30 or
Sec. 25.32 or an EA under Sec. 25.40. Annually, FDA's Center for
Veterinary Medicine has received approximately 810 claims for
categorical exclusion as required under Sec. 25.15(a) and (d) and 22
EAs as required under Sec. 25.40(a) and (c). Assuming an average of 10
claims per respondent, FDA estimates that approximately 81 respondents
will submit an average of 10 claims for categorical exclusion. FDA
further estimates that 22 respondents will submit an average of 1 EA.
FDA estimates that it takes sponsors/applicants approximately 3 hours
to prepare a claim of categorical exclusion and an average of 2,160
hours to prepare an EA.
Table 4--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)................ 81 10 810 3 2,430
25.40(a) and (c)................ 22 1 22 2,160 47,520
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 49,950
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
VI. 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. After
further review, the agency has concluded that the majority of the EA
burden for tobacco products
[[Page 63182]]
is covered under already existing information collections. To avoid
double counting, the agency has removed the burden which is approved
under other FDA information collections. The burden for SEs are
currently approved under OMB control number 0910-0673; the burden for
PMTAs are currently approved under OMB control number 0910-0768; the
burden for SE exemptions are currently approved under OMB control
number 0910-0684.
FDA's estimates are based on actual report data from fiscal year
(FY) 2015 to FY 2017, on average FDA estimated it received
approximately 27 modified risk tobacco product applications (MRTPAs)
from 27 respondents. Based on updated data for this collection, FDA
estimates 27 EAs from 27 respondents. A total of 27 respondents will
submit an average of 1 application for environmental assessment. 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 5--Estimated Annual Reporting Burden for Tobacco Products \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.40(a) and (c)................ 27 1 27 80 2,160
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The Estimated Annual Reporting Burden for Human Foods is no longer
a part of this information collection. The burden has now been
incorporated into OMB control number 0910-0541.
Our estimated burden for the information collection reflects an
overall decrease of 10,566 hours (currently approved 231,224) and a
corresponding decrease of 11,364 annual responses (currently approved
15,527). The new estimated totals are 220,658 hours and 4,163 annual
responses. We attribute this adjustment to the removal of the majority
tobacco burden from this collection, and the number of EA submissions
we received since the last extension.
Dated: November 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26556 Filed 12-6-18; 8:45 am]
BILLING CODE 4164-01-P
