[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59619-59622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23838]
-----------------------------------------------------------------------
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 27, 2012.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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 set forth in this document.
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)--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
[[Page 59620]]
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 nonexcluded actions.
This collection of information is used by FDA to assess the
environmental impact of Agency actions and to ensure that the public is
informed of environmental analyses. Firms wishing to manufacture and
market substances regulated under statues for which FDA is responsible
must, in most instances, submit applications requesting approval.
Environmental information must be included in such applications for the
purpose of determining whether the proposed action may have a
significant impact on the environment. Where significant adverse events
cannot be avoided, the Agency uses the submitted information as the
basis for preparing and circulating to the public an EIS, made
available through a Federal Register document also filed for comment at
the Environmental Protection Agency. The final EIS, including the
comments received, is reviewed by the Agency to weigh environmental
costs and benefits in determining whether to pursue the proposed action
or some alternative that would reduce expected environmental impact.
Any final EIS would contain additional information gathered by the
Agency after the publication of the draft EIS, a copy or a summary of
the comments received on the draft EIS, and the Agency's responses to
the comments, including any revisions resulting from the comments or
other information. When the Agency finds that no significant
environmental effects are expected, the Agency prepares a finding of no
significant impact.
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)(3), 21 CFR 314.50(d)(1)(iii), and 21
CFR 314.94(a)(9)(i), each investigational new drug application (IND),
new drug application (NDA), and abbreviated new drug application (ANDA)
must contain a claim for categorical exclusion under 25.30 or 25.31 or
an EA under 25.40. In 2011, FDA received 2,818 INDs from 2,064
sponsors, 99 NDAs from 79 applicants, 3,247 supplements to NDAs from
376 applicants, 5 biologic license applications (BLAs) from 5
applicants, 287 supplements to BLAs from 50 applicants, 895 ANDAs from
195 applicants, and 5,348 supplements to ANDAs from 299 applicants. FDA
estimates that it receives approximately 12,699 claims for categorical
exclusions as required under 25.15(a) and (d), and 10 EAs as required
under 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates
that approximately 3,175 respondents will submit an average of 4
applications for categorical exclusion and 10 respondents will submit
an average of 1 EA. Based on information provided by the pharmaceutical
industry, FDA estimates that it takes sponsors or applicants
approximately 8 hours to prepare a claim for a categorical exclusion
and approximately 3,400 hours to prepare an EA.
Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................ 3,175 4 12,700 8 101,600
25.40(a) and (c)................ 10 1 10 3,400 34,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 135,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Estimated Annual Reporting Burden for Human Foods
Under 21 CFR 71.1, 171.1, 170.39, and 170.100, food additive
petitions, color additive petitions, requests from exemption from
regulation as a food additive, and submission of a food contact
notification for a food contact substance must contain either a claim
of categorical exclusion under 25.30 or 25.32 or an EA under 25.40. In
2011, FDA received 97 industry submissions. FDA received an annual
average of 42 claims of categorical exclusions as required under
25.15(a) and (d), and 33 EAs as required under 25.40(a) and (c).
Therefore, over the next 3 years, FDA estimates that approximately 42
respondents will submit an average of 1 application for categorical
exclusion and 33 respondents will submit an average of 1 EA. FDA
estimates that, on average, it takes petitioners, notifiers, or
requestors approximately 3 hours to prepare a claim of categorical
exclusion and approximately 210 hours to prepare an EA.
Table 2--Estimated Annual Reporting Burden for Human Foods \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................ 42 1 42 8 336
[[Page 59621]]
25.40(a) and (c)................ 33 1 33 210 6,930
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 7,266
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Estimated Annual Reporting Burden for Medical Devices
Under 21 CFR 814.20(b)(11), premarket approvals (PMA) (original
PMAs and supplements) must contain a claim for categorical exclusion
under 25.30 or 25.34 or an EA under 25.40. In 2011, FDA received
approximately 52 claims (original PMAs and supplements) for categorical
exclusions as required under 25.15(a) and (d), and 0 EAs as required
under 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates
that approximately 52 respondents will submit an average of 1
application for categorical exclusion. Based on information provided by
less than 10 sponsors, FDA estimates that it takes approximately 6
hours to prepare a claim for a categorical exclusion.
Table 3--Estimated Annual Reporting Burden for Medical Devices \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15 (a) and (d).................................................. 52 1 52 6 312
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for Biological Products, Drugs, and
Medical Devices in the Center for Biologics Evaluation and Research
BLAs under 21 CFR 601.2(a), as well as INDs (21 CFR 312.23), NDAs
(21 CFR 314.50), ANDAs (21 CFR 314.94), and PMAs (21 CFR 814.20), must
contain either a claim of categorical exclusion under 25.30 or 25.32 or
an EA under 25.40. In 2011, FDA received 14 BLAs from 14 applicants,
831 BLA supplements to license applications from 153 applicants, 288
INDs from 210 sponsors, 1 NDA from 1 applicant, 37 supplements to NDAs
from 9 applicants, 1 ANDA from 1 applicant, 12 supplements to ANDAs
from 2 applicants, and 45 PMA supplements from 11 applicants. FDA
estimates that approximately 10 percent of these supplements would be
submitted with a claim for categorical exclusion or an EA.
FDA estimates that it received approximately 481 claims for
categorical exclusion as required under 25.15(a) and (d), and 2 EAs as
required under 25.40(a) and (c). Therefore, over the next 3 years, FDA
estimates that approximately 247 respondents will submit an average of
2 applications for categorical exclusion and 2 respondents will submit
an average of 1 EA. Based on information provided by industry, FDA
estimates that it takes sponsors and applicants approximately 8 hours
to prepare a claim of categorical exclusion and approximately 3,400
hours to prepare an EA for a biological product.
Table 4--Estimated Annual Reporting Burden for Biological Products \1\
----------------------------------------------------------------------------------------------------------------
Number of 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 25.30 or
25.33 or an EA under 25.40. In 2011, FDA's Center for Veterinary
Medicine has received approximately 698 claims for categorical
exclusion as required under 25.15(a) and (d), and 10 EAs as required
under 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates
that approximately 70 respondents will submit an average of 10
applications for categorical exclusion and 10 respondents will submit
an average of 1 EA. FDA estimates that it takes sponsors/applicants
approximately 3 hours to prepare a claim of categorical exclusion and
an average of 2,160 hours to prepare an EA.
[[Page 59622]]
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, Drugs, and
Cosmetic Act, premarket tobacco applications (PMTAs), applications for
substantial equivalence (SEs), Exemption from SEs, and modified risk
tobacco products must contain a claim for categorical exclusion under
25.30 or 25.34 or an EA under 25.40. In 2011, FDA estimated it will
receive approximately 20 PMTAs and supplements from 20 respondents, 150
reports intended to demonstrate the SE of a new tobacco product from
150 respondents, 500 exemption from SE requirements applications from
500 respondents, and 3 modified risk Tobacco product applications from
3 respondents for a total of 673 responses from 673 respondents. FDA
estimates that there were 538 claims from 538 respondents for
categorical exclusions as required under 25.15(a) and (d), and 135 EAs
from 135 respondents as required under 25.40(a) and (c). Therefore,
over the next 3 years, FDA estimates that approximately 538 respondents
will submit an average of 1 application for categorical exclusion and
135 respondents will submit an average of 1 EA. Based on FDA's
experience and previous information provided by potential sponsors, FDA
estimates that it takes approximately 12 hours to prepare a claim for a
categorical exclusion and 12 hours to prepare an EA.
Table 6--Estimated Annual Reporting Burden for Tobacco Products \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15 (a) and (d)............... 538 1 538 12 6,456
25.40 (a) and (c)............... 135 1 135 12 1,620
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 8,076
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 7--Estimated Annual Total Reporting Burden for All Centers \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.15 (a) and (d)............... 4,124 .............. 14,526 .............. 114,756
25.40 (a) and (c)............... 190 .............. 190 .............. 70,950
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 185,706
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23838 Filed 9-27-12; 8:45 am]
BILLING CODE 4160-01-P