Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations, 55484-55487 [06-8025]
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55484
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section
FDA Form
No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
514.80(b)(4)
2301
190
6.45
1,226
16
19,616
514.80(b)(5)(i)
2301
190
0.13
25
2
50
514.80(b)(5)(ii)
2301
190
4.06
772
2
1544
514.80(b)(5)(iii)
2301
530
0.11
56
2
112
Total Hours
1There
40,957
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
514.80(e)2
514.80(e)3
Total
1There
Annual Frequency
per Recordkeeping
530
530
Total Annual Records
36.58
4.49
Hours per Record
19,385
2,379
0.5
14
Total Hours
9,693
33,320
43,013
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates for § 514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Form FDA 1932.
estimates for § 514.80(b)(2)(iii), (b)(4), (b)(5), and (c); Form FDA 2301.
2Recordkeeping
3Recordkeeping
The reporting and recordkeeping
burden estimates for this collection of
information are based on the submission
of reports to the Division of
Surveillance, CVM. The total annual
response numbers are also based on the
submission of reports to the Division of
Surveillance, CVM. The annual
frequency of response was calculated as
the total annual responses divided by
the number of respondents.
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–8023 Filed 9–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0105]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
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.
VerDate Aug<31>2005
20:37 Sep 21, 2006
Jkt 208001
Fax written comments on the
collection of information by October 23,
2006.
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:
202–395–6974.
FOR FURTHER INFORMATION CONTACT: Liz
Berbakos, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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.
DATES:
Environmental Impact
Considerations—(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
PO 00000
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Fmt 4703
Sfmt 4703
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 (§ 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
E:\FR\FM\22SEN1.SGM
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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
an EIS, made available through a
Federal Register document also filed for
comment at the Environmental
Protection Agency (EPA). 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 of 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 (FONSI).
In the Federal Register of March 29,
2006 (71 FR 15753), FDA published a
60-day notice requesting public
comment on the information collection
provisions to which FDA received one
comment. The comment said it supports
the current FDA approach to assessing
potential environmental impact under
NEPA. However, the comment
questioned whether one aspect of the
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information has practical utility, and
contended that eliminating the
collection of information would
minimize the burden on respondents.
Specifically, the comment suggested
that FDA should ‘‘eliminate
unnecessary work’’ related to requests
for categorical exclusions for actions on
certain investigational new drug
applications (INDs). Section 25.31 lists
classes of actions that are categorically
excluded and, therefore, ordinarily do
not require the preparation of an EA or
an EIS. Section 25.31(e) lists an ‘‘action
on an IND’’ as one of these classes of
actions. The comment proposed that
§ 25.31(e) be amended as follows:
‘‘Action on INDs where the drug or
biologic product is derived from wild
plants or animals. Action on other types
of INDs do not require a claim for a
categorical exclusion.’’ The comment
proposed that categorical exclusions
should be automatically granted for
actions on INDs where the drug or
biologic products are not derived from
wild plants or animals.
The comment proposed this
amendment to § 25.31(e) for the
following reasons, each of which
suggests that claims for categorical
exclusion for action on an IND have
little practical utility and amending
§ 25.31(e) as proposed represents a way
to minimize the burden of the collection
of information:
1. FDA’s guidance document entitled
‘‘Environmental Assessment of Human
Drug and Biologics Applications’’ (July
1998) states: ‘‘INDs generally involve
relatively small quantities of a drug or
biologic product and treatment of a
limited number of patients. Many INDs
never result in the filing of an NDA or
application for marketing approval of a
biologic product, which would allow for
the wide-spread commercial sale of the
product. CDER and CBER will evaluate
INDs on a case-by-case basis where the
drug or biologic product is derived from
wild plants or animals to determine
whether the extraordinary circumstance
provision in § 25.21 is invoked.’’ (See
section III.C.3.b.ii of the guidance
document).
2. Pharmaceutical companies have
been providing claims for categorical
exclusion for action on an IND since the
early 1990’s for active pharmaceutical
ingredients (APIs) in all therapeutic
classes, and the companies have no
indication that FDA has used these
claims as the basis for denials pertinent
to potential environmental impact as
described under NEPA.
3. Usage of an API under an IND is
‘‘site limited and time bounded,’’
indicating that ‘‘the potential for patient
excretion of an API to the environment
is extremely limited.’’
4. The potential risk from
pharmaceuticals in the environment
pertains to long-term, chronic exposure,
and usage of an API under an IND will
not result in the type of exposure widely
accepted as being of potential
environmental concern. The comment
also stated that prior to marketing
approval of an API, FDA will have the
opportunity to review potential
55485
environmental impact through its EA
requirements.
5. The comment concluded that
amending § 25.31(e) as proposed would
have ‘‘eliminated work on up to 1933
categorical exclusions (15,464 hours) for
INDs in 2005 that ultimately had no
practical utility.’’
FDA appreciates the comment
requesting that § 25.31(e) be amended so
that categorical exclusions could be
automatically granted for actions on
INDs where the drug or biologic
products are not derived from wild
plants or animals. The purpose of the
March 29, 2006, Federal Register notice
and this notice, however, is to afford an
opportunity for comment on the
information collection requirements and
burden estimates for part 25, and to
request that OMB extend approval for
that collection. Because the comment
requests a rulemaking change, we have
forwarded it to the office in each center
that is responsible for the information
collection requirements in part 25 so
that the comment may be considered for
any future amendments to the
regulations.
FDA estimates the burden of this
collection of information as follows:
Estimated Annual Reporting Burden for
Human Drugs
Under 21 CFR 312.23(a)(7)(iv)(e),
314.50(d)(1)(iii), and 314.94(a)(9)(i),
each 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 2005,
FDA received 1,933 INDs from 1,517
sponsors, 114 NDAs from 94 applicants,
2,682 supplements to NDAs from 293
applicants, 777 ANDAs from 161
applicants, and 4,318 supplements to
ANDAs from 219 applicants. FDA
estimates that it receives approximately
9,813 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 DRUGS1
sroberts on PROD1PC70 with NOTICES
21 CFR Section
No. of Respondents
25.15(a) and (d)
25.40(a) and (c)
Total
1There
Annual Frequency per
Response
2,284
11
Total Annual Responses
4.32
1
Hours per Respondent
9,813
11
8
3,400
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total Hours
78,504
37,400
115,904
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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
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
§ 25.30 or § 25.32, or an EA under
§ 25.40. From 2003 to 2005, FDA
received an annual average of 88
industry submissions. FDA estimates
that it received an annual average of 57
claims of categorical exclusions as
required under § 25.15(a) and (d), and
31 EAs as required under § 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 FOODS1
No. of Respondents
21 CFR Section
25.15(a) and (d)
25.40(a) and (c)
Total
1There
Annual Frequency per
Response
57
31
Total Annual
Responses
1.4
1.3
Hours per Respondent
80
39
Total Hours
3
210
240
8,190
8,430
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 (original premarket
approval applications (PMAs) and
supplements) must contain a claim for
categorical exclusion under § 25.30 or
§ 25.34 or an EA under § 25.40. In 2005,
FDA received 282 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). Based on information
provided by less than 10 sponsors, FDA
estimates that it takes approximately
less than 1 hour 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 DEVICES1
21 CFR Section
25.15(a) and (d)
25.40(a) and (c)
Total
1There
Annual Frequency
per Response
No. of Respondents
47
0
Total Annual Responses
6
0
Hours per Respondent
282
0
Total Hours
1
0
282
0
282
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Biological Products
Under 21 CFR 312.23(a)(7)(iv)(e) and
601.2(a), IND and biologics license
applications (BLAs) must contain a
claim for categorical exclusion under
§ 25.30 or § 25.31 or an EA under
§ 25.40. In 2005, FDA received 565 INDs
from 426 sponsors, 27 BLAs from 12
applicants, and 737 BLA supplements to
license applications from 205
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 666 claims for categorical
exclusion as required under § 25.15(a)
and (d), and 2 EAs as required under
§ 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 PRODUCTS1
No. of Respondents
21 CFR Section
25.15(a) and (d)
25.40(a) and (c)
Total
sroberts on PROD1PC70 with NOTICES
1There
Annual Frequency
per Response
459
2
Total Annual Responses
1.45
1
Hours per Respondent
666
2
8
3,400
Total Hours
5,328
6,800
12,128
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), NADAs
and ANADAs, § 514.8(a)(1)
supplemental NADAs and ANADAs,
§ 511.1 (b)(10) investigational new
animal drug applications (INADs),
§ 570.35 (c)(1)(viii) generally recognized
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as safe (GRAS) affirmation petitions,
and § 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 2005, the Center
for Veterinary Medicine (CVM) has
received approximately 421 claims for
categorical exclusion as required under
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Sfmt 4703
§ 25.15(a) and (d), and 14 EAs as
required under § 25.40(a) and (c). Based
on information provided by industry,
FDA estimates that it takes sponsors/
applicants approximately 8 hours to
prepare a claim for a categorical
exclusion and an average of 2,160 hours
to prepare an EA.
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55487
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS1
21 CFR Section
No. of Respondents
25.15(a) and (d)
25.40(a) and (c)
Total
1There
134
12
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–8025 Filed 9–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0380]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Export of Medical
Devices-Foreign Letters of Approval
Food and Drug Administration
Notice.
AGENCY:
sroberts on PROD1PC70 with NOTICES
Total Annual Responses
3.9
1.6
Hours per Respondent
421
14
8
2,160
Total Hours
3,368
30,240
33,608
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on information provided by
industry, FDA estimates that the
combined annual total burden hours for
all centers is 170,352.
ACTION:
Annual Frequency per
Response
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 information
collection, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
reporting requirements for firms that
intend to export certain unapproved
medical devices.
DATES: Submit written or electronic
comments on the collection of
information by November 21, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
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20:37 Sep 21, 2006
Jkt 208001
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:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,301–827–1472.
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.
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Sfmt 4703
Export of Medical Devices-Foreign
Letters of Approval (OMB Control
Number 0910–0264)—Extension
Section 801(e)(2) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 381(e)(2)) provides for the
exportation of an unapproved device
under certain circumstances if the
exportation is not contrary to the public
health and safety and it has the approval
of the foreign country to which it is
intended for export.
Requesters communicate (either
directly or through a business associate
in the foreign country) with a
representative of the foreign government
to which they seek exportation, and
written authorization must be obtained
from the appropriate office within the
foreign government approving the
importation of the medical device. An
alternative to obtaining written
authorization from the foreign
government is to accept a notarized
certification from a responsible
company official in the United States
that the product is not in conflict with
the foreign country’s laws. This
certification must include a statement
acknowledging that the responsible
company official making the
certification is subject to the provisions
of 18 U.S.C. 1001. This statutory
provision makes it a criminal offense to
knowingly and willingly make a false or
fraudulent statement, or make or use a
false document, in any manner within
the jurisdiction of a department or
agency of the United States.
FDA uses the written authorization
from the foreign country or the
certification from a responsible
company official in the United States to
determine whether the foreign country
has any objection to the importation of
the device into their country.
The respondents to this collection of
information are companies that seek to
export medical devices.
FDA estimates the reporting burden of
this collection of information as follows:
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]]>Agencies
[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55484-55487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8025]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0105]
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 October
23, 2006.
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: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Liz Berbakos, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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
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
[[Page 55485]]
an EIS, made available through a Federal Register document also filed
for comment at the Environmental Protection Agency (EPA). 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 of 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 (FONSI).
In the Federal Register of March 29, 2006 (71 FR 15753), FDA
published a 60-day notice requesting public comment on the information
collection provisions to which FDA received one comment. The comment
said it supports the current FDA approach to assessing potential
environmental impact under NEPA. However, the comment questioned
whether one aspect of the collection of information is necessary for
the proper performance of FDA's functions, including whether the
information has practical utility, and contended that eliminating the
collection of information would minimize the burden on respondents.
Specifically, the comment suggested that FDA should ``eliminate
unnecessary work'' related to requests for categorical exclusions for
actions on certain investigational new drug applications (INDs).
Section 25.31 lists classes of actions that are categorically excluded
and, therefore, ordinarily do not require the preparation of an EA or
an EIS. Section 25.31(e) lists an ``action on an IND'' as one of these
classes of actions. The comment proposed that Sec. 25.31(e) be amended
as follows: ``Action on INDs where the drug or biologic product is
derived from wild plants or animals. Action on other types of INDs do
not require a claim for a categorical exclusion.'' The comment proposed
that categorical exclusions should be automatically granted for actions
on INDs where the drug or biologic products are not derived from wild
plants or animals.
The comment proposed this amendment to Sec. 25.31(e) for the
following reasons, each of which suggests that claims for categorical
exclusion for action on an IND have little practical utility and
amending Sec. 25.31(e) as proposed represents a way to minimize the
burden of the collection of information:
1. FDA's guidance document entitled ``Environmental Assessment of
Human Drug and Biologics Applications'' (July 1998) states: ``INDs
generally involve relatively small quantities of a drug or biologic
product and treatment of a limited number of patients. Many INDs never
result in the filing of an NDA or application for marketing approval of
a biologic product, which would allow for the wide-spread commercial
sale of the product. CDER and CBER will evaluate INDs on a case-by-case
basis where the drug or biologic product is derived from wild plants or
animals to determine whether the extraordinary circumstance provision
in Sec. 25.21 is invoked.'' (See section III.C.3.b.ii of the guidance
document).
2. Pharmaceutical companies have been providing claims for
categorical exclusion for action on an IND since the early 1990's for
active pharmaceutical ingredients (APIs) in all therapeutic classes,
and the companies have no indication that FDA has used these claims as
the basis for denials pertinent to potential environmental impact as
described under NEPA.
3. Usage of an API under an IND is ``site limited and time
bounded,'' indicating that ``the potential for patient excretion of an
API to the environment is extremely limited.''
4. The potential risk from pharmaceuticals in the environment
pertains to long-term, chronic exposure, and usage of an API under an
IND will not result in the type of exposure widely accepted as being of
potential environmental concern. The comment also stated that prior to
marketing approval of an API, FDA will have the opportunity to review
potential environmental impact through its EA requirements.
5. The comment concluded that amending Sec. 25.31(e) as proposed
would have ``eliminated work on up to 1933 categorical exclusions
(15,464 hours) for INDs in 2005 that ultimately had no practical
utility.''
FDA appreciates the comment requesting that Sec. 25.31(e) be
amended so that categorical exclusions could be automatically granted
for actions on INDs where the drug or biologic products are not derived
from wild plants or animals. The purpose of the March 29, 2006, Federal
Register notice and this notice, however, is to afford an opportunity
for comment on the information collection requirements and burden
estimates for part 25, and to request that OMB extend approval for that
collection. Because the comment requests a rulemaking change, we have
forwarded it to the office in each center that is responsible for the
information collection requirements in part 25 so that the comment may
be considered for any future amendments to the regulations.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden for Human Drugs
Under 21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i), each 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 2005, FDA received 1,933 INDs from 1,517 sponsors, 114 NDAs from 94
applicants, 2,682 supplements to NDAs from 293 applicants, 777 ANDAs
from 161 applicants, and 4,318 supplements to ANDAs from 219
applicants. FDA estimates that it receives approximately 9,813 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual
21 CFR Section No. of Respondents Response Responses Hours per Respondent Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 2,284 4.32 9,813 8 78,504
25.40(a) and (c) 11 1 11 3,400 37,400
Total .................... .................... .................... .................... 115,904
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 55486]]
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. From 2003 to 2005, FDA received an annual average
of 88 industry submissions. FDA estimates that it received an annual
average of 57 claims of categorical exclusions as required under Sec.
25.15(a) and (d), and 31 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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Respondent Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 57 1.4 80 3 240
25.40(a) and (c) 31 1.3 39 210 8,190
Total .............. .................... .............. .............. 8,430
----------------------------------------------------------------------------------------------------------------
\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 (original premarket
approval applications (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 2005, FDA received 282 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 less than 1 hour 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\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
21 CFR Section No. of Respondents per Response Responses Respondent Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 47 6 282 1 282
25.40(a) and (c) 0 0 0 0 0
Total .................... ................. ................. ................. 282
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for Biological Products
Under 21 CFR 312.23(a)(7)(iv)(e) and 601.2(a), IND and biologics
license applications (BLAs) must contain a claim for categorical
exclusion under Sec. 25.30 or Sec. 25.31 or an EA under Sec. 25.40.
In 2005, FDA received 565 INDs from 426 sponsors, 27 BLAs from 12
applicants, and 737 BLA supplements to license applications from 205
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 666 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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Respondents per Response Responses Hours per Respondent Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 459 1.45 666 8 5,328
25.40(a) and (c) 2 1 2 3,400 6,800
Total .............. ................. ................. .................... 12,128
----------------------------------------------------------------------------------------------------------------
\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), NADAs and ANADAs, Sec. 514.8(a)(1)
supplemental NADAs and ANADAs, Sec. 511.1 (b)(10) investigational new
animal drug applications (INADs), Sec. 570.35 (c)(1)(viii) generally
recognized as safe (GRAS) affirmation petitions, and Sec. 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 2005,
the Center for Veterinary Medicine (CVM) has received approximately 421
claims for categorical exclusion as required under Sec. 25.15(a) and
(d), and 14 EAs as required under Sec. 25.40(a) and (c). Based on
information provided by industry, FDA estimates that it takes sponsors/
applicants approximately 8 hours to prepare a claim for a categorical
exclusion and an average of 2,160 hours to prepare an EA.
[[Page 55487]]
Table 5.--Estimated Annual Reporting Burden for Animal Drugs\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual Hours per
21 CFR Section No. of Respondents Response Responses Respondent Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and 134 3.9 421 8 3,368
(d)
25.40(a) and 12 1.6 14 2,160 30,240
(c)
Total .................... .................... ................. ................. 33,608
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on information provided by industry, FDA estimates that the
combined annual total burden hours for all centers is 170,352.
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8025 Filed 9-21-06; 8:45 am]
BILLING CODE 4160-01-S
