[Federal Register Volume 68, Number 51 (Monday, March 17, 2003)]
[Notices]
[Pages 12702-12705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0085]


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 electric comments on the collection of 
information by May 16, 2003.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: Karen Nelson, Office of Information 
Resources Management (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: (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;

[[Page 12703]]

(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 entitled ``Environmental Impact 
Considerations.''
    The National Environmental Policy Act of 1969 (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.
    FDA's NEPA regulations are at 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 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 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 Frequency per      Total Annual       Hours per    Total Burden
  21 CFR Section    No. of Respondents         Response               Records         Response         Hours
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25.15(a) and (d)        2,031                     4.32              8,771                 8        70,168
25.40(a) and (c)           22                     1                    22             3,400        74,800
Total               ..................  ......................  ..................  ............  144,968
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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 171.1, 71.1, 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 Frequency per      Total Annual       Hours per    Total Burden
  21 CFR Section    No. of Respondents         Response               Records         Response         Hours
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25.15(a) and (d)           56                     1.6                  87                 4           348
25.40(a) and (c)           18                     1.7                  31               210         6,510

[[Page 12704]]

 
Total               ..................  ......................  ..................  ............    6,858
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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 Frequency per      Total Annual       Hours per    Total Burden
  21 CFR Section    No. of Respondents         Response               Records         Response         Hours
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25.15(a) and (d)           94                     6                   568                 1           568
25.40(a) and (c)            0                     0                     0                 0             0
Total               ..................  ......................  ..................  ............      568
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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.

                     Table 4.--Estimated Annual Reporting Burden for Biological Products\1\
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                                         Annual Frequency per      Total Annual       Hours per    Total Burden
  21 CFR Section    No. of Respondents         Response               Records         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.

    Under 21 CFR 514.1(b)(14), new animal drug applications (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 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 Frequency per      Total Annual       Hours per    Total Burden
  21 CFR Section    No. of Respondents         Response               Records         Response         Hours
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25.15(a) and (d)          139                     3.9                 549                 8         4,392
25.40(a) and (c)           14                     1.4                  19             2,160        41,040
Total               ..................  ......................  ..................  ............   45,432
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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 is as 
follows:

[[Page 12705]]



                      Table 6.--Total Estimated Annual Reporting Burden For All Centers\1\
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                                         Annual Frequency per      Total Annual       Hours per    Total Burden
  21 CFR Section    No. of Respondents         Response               Records         Response         Hours
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25.15(a) and (d)       70,168                   348                   568             5,592        76,676
25.40(a) and (c)       74,800                 6,510                     0             6,800        88,110
Total               ..................  ......................  ..................  ............  164,786
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    Dated: March 10, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-6228 Filed 3-14-03; 8:45 am]
BILLING CODE 4160-01-S