[Federal Register: June 26, 2003 (Volume 68, Number 123)]
[Notices]
[Page 38063-38065]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn03-95]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0085]
Agency Information Collection Activities; Submission for OMB
Review; 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 that the
proposed collection of information listed below 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 July
28, 2003.
ADDRESSES: The Office of Management and Budget (OMB) is still
experiencing significant delays in the regular mail, including first
class and express mail, and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk
Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information
Resources Management (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--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 entitled ``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 (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 (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.
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 Sec. 25.30 or
Sec. 25.31 or an EA under Sec. 25.40. In 2002, FDA received 2,374
INDs from 1,809 sponsors, 109 NDAs from 79 applicants, 2,575
supplements to NDAs from 276 applicants, 392 ANDAs from 107 applicants,
and 3,343 supplements to ANDAs from 222
[[Page 38064]]
applicants. FDA estimates that it receives approximately 8,771 claims
for categorical exclusions as required under Sec. 25.15(a) and (d),
and 22 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\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Burden
Respondents Response Responses Response Hours
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25.15(a) and (d) 2,031 4.32 8,773 8 70,184
25.40(a) and (c) 22 1 22 3,400 74,800
Total .............. .............. .............. .............. 144,984
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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 premarket
notification for a food contact substance must contain a claim of
categorical exclusion under Sec. 25.30 or Sec. 25.32 or an EA under
Sec. 25.40. In 2002, FDA received 12 food additive petitions and 106
food contact substance notifications. FDA estimates that it received
approximately 87 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 it takes petitioners or requestors
approximately 8 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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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Burden
Respondents Response Responses Response Hours
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25.15(a) and (d) 56 1.6 89 4 356
25.40(a) and (c) 18 1.7 31 210 6,510
Total .............. .............. .............. .............. 6,866
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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 1998,
FDA received 568 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\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Burden
Respondents Response Responses Response Hours
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25.15(a) and (d) 94 6 564 1 564
25.40(a) and (c) 0 0 0 0 0
Total .............. .............. .............. .............. 564
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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 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 2001, FDA received 535 INDs from 376 sponsors, 80 BLAs from 22
applicants, and 837 BLA supplements to license applications from 168
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 699 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.
[[Page 38065]]
Table 4.--Estimated Annual Reporting Burden for Biological Products\1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Burden
Respondents Response Responses Response Hours
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25.15(a) and (d) 415 1.68 699 8 5,592
25.40(a) and (c) 2 1 2 3,400 6,800
Total .............. .............. .............. .............. 12,392
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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 Sec. 514.1(b)(14) (21 CFR 514.1(b)(14)), new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs), Sec. 514.8(a)(1) supplemental NADAs and ANADAs, 21 CFR
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 Sec. 25.30 or Sec. 25.33 or an EA
under Sec. 25.40. Since the last OMB approval of these collections of
information, FDA's Center of Veterinary Medicine has received
approximately 547 claims for categorical exclusion as required under
Sec. 25.15(a) and (d), and 19 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.
Table 5.--Estimated Annual Reporting Burden for Animal Drugs\1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Burden
Respondents Response Responses Response Hours
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25.15(a) and (d) 139 3.9 542 8 4,336
25.40(a) and (c) 14 1.4 19 2,160 41,040
Total .............. .............. .............. .............. 45,376
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\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 burden for the environmental impact considerations--part 25 is
as follows:
Table 6.--Estimated Annual Reporting Burden for All Centers\1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Burden
Respondents Response Responses Response Hours
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25.15(a) and (d) 2,735 17.5 10,768 29 81,032
25.40(a) and (c) 56 5.1 74 9,199 129,150
Total .............. .............. .............. .............. 210,182
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
In the Federal Register of March 17, 2003 (68 FR 12702), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Dated: June 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16107 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S