[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Notices]
[Pages 46430-46432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21724]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 46431]]

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\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                3,171                  3.37             10,686                  8             85,488
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                   20                     1                 20              3,400             68,000
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                    153,488
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                   40                   1.7                 68                  3                204
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                   24                   1.9                 45                210              9,450
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      9,654
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                   39                     1                 39                  6                234
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                    1                     1                  1                  1                  1
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                        235
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                  210                  1.76                370                  8              2,960
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                    2                  1                     2              3,400              6,800
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      9,760
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and                   65                  10.4                676                  5              3,380
 (d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and                    6                   1.3                  8              2,160             17,280
 (c)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     20,660
----------------------------------------------------------------------------------------------------------------
\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
------------------------------------------------------------------------
------------------------------------------------------------------------


    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