Notice: Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Environmental Impact 
Considerations

Federal Register: January 5, 2010 (Volume 75, Number 2)              
                  Page 379-382

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 
February 4, 2010.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0322. 
Also include the FDA 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, 
Elizabeth.Berbakos@fda.hhs.gov.

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--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.
    FDA's 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

[[Page 380]]

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 (FONSI).

Estimated Annual Reporting Burden for Human Drugs (Including Biologics 
in the Center for Devices and Radiological Health)

    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 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  per      Total Annual        Hours per
                   21 CFR Section                       Respondents             Response             Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                                                    40                     1.7                  68                  3                204
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c)                                                    24                     1.9                  45                210              9,450
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 environmental assessment 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.

[[Page 381]]



                       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.

Estimated Annual Reporting Burden for Biological Products in the Center 
for Biologics Evaluation and Research

    Under Sec.  312.23(a)(7)(iv)(e) and 21 CFR 601.2(a), IND 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); Sec.  514.8(a)(1) 
supplemental NADAs and ANADAs; Sec.  511.1(b)(10) investigational new 
animal drug applications (INADs); 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 2008, FDA's Center 
for Veterinary Medicine has 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  per      Total Annual        Hours per
                   21 CFR Section                       Respondents             Response             Responses           Response          Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                                                    65                    10.4                 676                  5              3,380
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c)                                                     6                     1.3                   8              2,160             17,280
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------


[[Page 382]]

    In the Federal Register of September 9, 2009 (74 FR 46430), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

    Dated: December 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-31199 Filed 1-4-10; 8:45 am]

BILLING CODE 4160-01-S