[Federal Register: September 9, 2009 (Volume 74, Number 173)]
[Notices]
[Page 46430-46432]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se09-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0372]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Environmental Impact Considerations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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
contained in FDA regulations entitled ``Environmental Impact
Considerations.''
DATES: Submit written or electronic comments on the collection of
information by November 9, 2009.
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: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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 regulation ``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.
The FDA NEPA regulations are in part 25 (21 CFR part 25). All
applications or petitions requesting agency action require the
submission of a claim for a 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 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 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
effects 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's after the publication of the draft EIS, a copy of or a summary
of the comments received on the draft EIS, and
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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 (FONSI).
Estimated Annual Reporting Burden for Human Drugs (including biologics
in the Center for Drug Evaluation and Research)
Under Sec. 312.23(a)(7)(iv)(e) (21 CFR 312.23(a)(7)(iv)(e)), 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 Sec. 25.30 or Sec. 25.31 or an EA under Sec. 25.40.
In 2008, FDA received 2,550 INDs from 2,026 sponsors; 106 NDAs from 88
applicants; 2,856 supplements to NDAs from 615 applicants; 13 biologics
license applications (BLAs) from 9 applicants; 206 supplements to BLAs
from 64 applicants; 835 ANDAs from 165 applicants; and 4,143
supplements to ANDAs from 224 applicants. FDA estimates that it
receives approximately 10,689 claims for categorical exclusions as
required under Sec. 25.15(a) and (d), and 20 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden for Human Drugs\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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25.15(a) and 3,171 3.37 10,686 8 85,488
(d)
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25.40(a) and 20 1 20 3,400 68,000
(c)
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Total 153,488
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\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 for exemption from
regulation as a food additive, and submission of a food contact
notification (FCN) 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. In 2008, FDA received 112 industry submissions.
FDA received an annual average of 67 claims of categorical exclusions
as required under Sec. 25.15(a) and (d), and 45 EAs as required under
Sec. 25.40(a) and (c). 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\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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25.15(a) and 40 1.7 68 3 204
(d)
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25.40(a) and 24 1.9 45 210 9,450
(c)
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Total 9,654
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Estimated Annual Reporting Burden for Medical Devices
Under 21 CFR 814.20(b)(11), premarket approvals (PMAs) (original
PMAs and supplements) must contain a claim for categorical exclusion
under Sec. 25.30 or Sec. 25.34 or an EA under Sec. 25.40. In 2008,
FDA received approximately 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). 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 and an unknown number of hours to prepare an EA.
Table 3.--Estimated Annual Reporting Burden for Medical Devices\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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25.15(a) and 39 1 39 6 234
(d)
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25.40(a) and 1 1 1 1 1
(c)
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Total 235
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 46432]]
Estimated Annual Reporting Burden for Biological Products in the Center
for Biologics Evaluation and Research
Under Sec. 312.23(a)(7)(iv)(e) and 601.2(a), INDs and BLAs must
contain a claim for categorical exclusion under Sec. 25.30 or Sec.
25.31 or an EA under Sec. 25.40. In 2008, FDA received 245 INDs from
180 sponsors, 28 BLAs from 13 applicants, and 972 BLA supplements to
license applications from 173 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 370 claims for
categorical exclusion as required under Sec. 25.15(a) and (d), and 2
EAs as required under Sec. 25.40(a) and (c). Based on information
provided by industry, FDA estimates that it takes sponsors and
applicants approximately 8 hours to prepare a claim for 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\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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25.15(a) and 210 1.76 370 8 2,960
(d)
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25.40(a) and 2 1 2 3,400 6,800
(c)
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Total 9,760
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\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. In 2008, FDA's Center
for Veterinary Medicine received approximately 676 claims for
categorical exclusion as required under Sec. 25.15(a) and (d), and 8
EAs as required under Sec. 25.40(a) and (c). FDA estimates that it
takes sponsors/applicants approximately 5 hours to prepare a claim for
a categorical exclusion and an average of 2,160 hours to prepare an EA.
Table 5.--Estimated Annual Reporting Burden for Animal Drugs\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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25.15(a) and 65 10.4 676 5 3,380
(d)
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25.40(a) and 6 1.3 8 2,160 17,280
(c)
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Total 20,660
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 6.--Combined Estimated Annual Total Burden Hours for All Centers
Total 193,797
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Dated: August 28, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21724 Filed 9-8-09; 8:45 am]
BILLING CODE 4160-01-S