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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0105]

Agency Information Collection Activities: Proposed Collection; Comment
Request; Environmental Impact Considerations
AGENCY:
ACTION:

Food and Drug Administration, HHS.

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 contained in FDA regulations entitled
‘‘Environmental Impact Considerations.’’
DATES:

Submit written or electronic comments on the collection of information

by [insert date 60 days after date of publication in the Federal Register].
ADDRESSES:

Submit electronic comments on the collection of information to:

http://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. 1061, Rockville, MD
20857. All comments should be identified with the docket number found in
brackets in the heading of this document.

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FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management

Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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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Environmental Impact Considerations—Part 25 (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 at 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 (§ 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.
Sections 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,

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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 (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).
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
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 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

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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 BURDEN1
Estimated Annual Reporting Burden for Human Drugs
21 CFR Section

No. of
Respondents

Annual Frequency
per Response

Total Annual
Responses

Hours per
Response

Total Burden
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

1There

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 § 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 BURDEN1
Estimated Annual Reporting Burden for Human Foods
21 CFR Section

No. of
Respondents

Annual Frequency
per Response

Total Annual
Responses

Hours per
Response

Total Burden
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
1There

8,430
are no capital costs or operating and maintenance costs associated with this collection of information.

Estimated Annual Reporting Burden for Medical Devices

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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 BURDEN1
Estimated Annual Reporting Burden for Medical Devices
21 CFR Section

No. of
Respondents

Annual Frequency
per Response

Total Annual
Responses

Hours per
Response

Total Burden
Hours

25.15(a) and (d)

47

6

282

1

282

25.40(a) and (c)

0

0

0

0

0

Total

282

1There

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

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for categorical exclusion and approximately 3,400 hours to prepare an EA for
a biological product.
TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN1
Estimated Annual Reporting Burden for Biological Products
21 CFR Section

No. of
Respondents

Annual Frequency
per Response

Total Annual
Responses

Hours per
Response

Total Burden
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

1There

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), § 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 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, FDA’s Center for Veterinary Medicine (CVM) has
received approximately 421 claims for categorical exclusion as required under
§ 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.
TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN1
Estimated Annual Reporting Burden for Animal Drugs
21 CFR Section

No. of
Respondents

Annual Frequency
per Response

Total Annual
Responses

Hours per
Response

Total Burden
Hours

25.15(a) and (d)

135

3.9

421

8

3,368

25.40(a) and (c)

12

1.6

14

2,160

30,240

Total
1There

33,608
are no capital costs or operating and maintenance costs associated with this collection of information.

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Based on information provided by industry, FDA estimates that the
combined annual total burden hours for all Centers is 170,352.
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–????? Filed ??–??–06; 8:45 am]
BILLING CODE 4160–01–S