[Federal Register Volume 71, Number 60 (Wednesday, March 29, 2006)]
[Notices]
[Pages 15753-15756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4507]


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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: 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.''

[[Page 15754]]


DATES: Submit written or electronic comments on the collection of 
information by May 30, 2006.

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.

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.

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 (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. 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, 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 Sec.  25.30 or 
Sec.  25.31 or an EA under Sec.  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 Sec.  25.15(a) and (d), and 11 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:

[[Page 15755]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                    Estimated Annual Reporting Burden for Human Drugs
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                                                              No. of         Annual Frequency       Total Annual        Hours per         Total Burden
                    21 CFR Section                         Respondents         per Response          Responses           Response            Hours
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25.15(a) and (d)                                                    2,284                  4.32              9,813                  8             78,504
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25.40(a) and (c)                                                       11                     1                 11              3,400             37,400
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Total                                                                                                                                           115,904
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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 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. 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 Sec.  
25.15(a) and (d), and 31 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\1\
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                                                    Estimated Annual Reporting Burden for Human Foods
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                                                              No. of         Annual Frequency       Total Annual        Hours per         Total Burden
                    21 CFR Section                         Respondents         per Response          Responses           Response            Hours
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25.15(a) and (d)                                                       57                   1.4                 80                  3                240
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25.40(a) and (c)                                                       31                   1.3                 39                210              8,190
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Total                                                                                                                                             8,430
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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 (original premarket 
approval applications (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 2005, FDA received 282 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\1\
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                                                  Estimated Annual Reporting Burden for Medical Devices
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                                                              No. of         Annual Frequency       Total Annual        Hours per         Total Burden
                    21 CFR Section                         Respondents         per Response          Responses           Response            Hours
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25.15(a) and (d)                                                       47                     6                282                  1                282
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25.40(a) and (c)                                                        0                     0                  0                  0                  0
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Total                                                                                                                                               282
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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 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 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 15756]]



                                                     Table 4.--Estimated Annual Reporting Burden\1\
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                                                Estimated Annual Reporting Burden for Biological Products
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                                                              No. of         Annual Frequency       Total Annual        Hours per         Total Burden
                    21 CFR Section                         Respondents         per Response          Responses           Response            Hours
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25.15(a) and (d)                                                      459                  1.45                666                  8              5,328
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25.40(a) and (c)                                                        2                     1                  2              3,400              6,800
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Total                                                                                                                                            12,128
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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 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), Sec.  570.35 (c)(1)(viii) generally 
recognized as safe (GRAS) affirmation petitions, 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 2005, 
FDA's Center for Veterinary Medicine (CVM) has received approximately 
421 claims for categorical exclusion as required under Sec.  25.15(a) 
and (d), and 14 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\1\
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                                                   Estimated Annual Reporting Burden for Animal Drugs
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                                                              No. of         Annual Frequency       Total Annual        Hours per         Total Burden
                    21 CFR Section                         Respondents         per Response          Responses           Response            Hours
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25.15(a) and (d)                                                      135                   3.9                421                  8              3,368
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25.40(a) and (c)                                                       12                   1.6                 14              2,160             30,240
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Total                                                                                                                                            33,608
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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 annual total burden hours for all Centers is 170,352.

    Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4507 Filed 3-28-06; 8:45 am]
BILLING CODE 4160-01-S