
[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59619-59622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23838]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0961]


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 
entitled ``Environmental Impact Considerations.''

DATES: Submit either electronic or written comments on the collection 
of information by November 27, 2012.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
daniel.gittleson@fda.hhs.gov.

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 collection of information ``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

[[Page 59620]]

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 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 (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 statues 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 events 
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 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.
    FDA estimates the burden of this collection of information as 
follows:

Estimated Annual Reporting Burden for Human Drugs (Including Biologics 
in the Center for Drug Evaluation and Research)

    Under 21 CFR 312.23(a)(7)(iv)(3), 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 25.30 or 25.31 or 
an EA under 25.40. In 2011, FDA received 2,818 INDs from 2,064 
sponsors, 99 NDAs from 79 applicants, 3,247 supplements to NDAs from 
376 applicants, 5 biologic license applications (BLAs) from 5 
applicants, 287 supplements to BLAs from 50 applicants, 895 ANDAs from 
195 applicants, and 5,348 supplements to ANDAs from 299 applicants. FDA 
estimates that it receives approximately 12,699 claims for categorical 
exclusions as required under 25.15(a) and (d), and 10 EAs as required 
under 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates 
that approximately 3,175 respondents will submit an average of 4 
applications for categorical exclusion and 10 respondents will submit 
an average of 1 EA. 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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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15(a) and (d)................           3,175               4          12,700               8         101,600
25.40(a) and (c)................              10               1              10           3,400          34,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         135,600
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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 from 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 25.30 or 25.32 or an EA under 25.40. In 
2011, FDA received 97 industry submissions. FDA received an annual 
average of 42 claims of categorical exclusions as required under 
25.15(a) and (d), and 33 EAs as required under 25.40(a) and (c). 
Therefore, over the next 3 years, FDA estimates that approximately 42 
respondents will submit an average of 1 application for categorical 
exclusion and 33 respondents will submit an average of 1 EA. 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\
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15(a) and (d)................              42               1              42               8             336

[[Page 59621]]

 
25.40(a) and (c)................              33               1              33             210           6,930
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           7,266
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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 (PMA) (original 
PMAs and supplements) must contain a claim for categorical exclusion 
under 25.30 or 25.34 or an EA under 25.40. In 2011, FDA received 
approximately 52 claims (original PMAs and supplements) for categorical 
exclusions as required under 25.15(a) and (d), and 0 EAs as required 
under 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates 
that approximately 52 respondents will submit an average of 1 
application for categorical exclusion. 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.

                                           Table 3--Estimated Annual Reporting Burden for Medical Devices \1\
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                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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25.15 (a) and (d)..................................................              52                1               52                6              312
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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, Drugs, and 
Medical Devices in the Center for Biologics Evaluation and Research

    BLAs under 21 CFR 601.2(a), as well as INDs (21 CFR 312.23), NDAs 
(21 CFR 314.50), ANDAs (21 CFR 314.94), and PMAs (21 CFR 814.20), must 
contain either a claim of categorical exclusion under 25.30 or 25.32 or 
an EA under 25.40. In 2011, FDA received 14 BLAs from 14 applicants, 
831 BLA supplements to license applications from 153 applicants, 288 
INDs from 210 sponsors, 1 NDA from 1 applicant, 37 supplements to NDAs 
from 9 applicants, 1 ANDA from 1 applicant, 12 supplements to ANDAs 
from 2 applicants, and 45 PMA supplements from 11 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 481 claims for 
categorical exclusion as required under 25.15(a) and (d), and 2 EAs as 
required under 25.40(a) and (c). Therefore, over the next 3 years, FDA 
estimates that approximately 247 respondents will submit an average of 
2 applications for categorical exclusion and 2 respondents will submit 
an average of 1 EA. Based on information provided by industry, FDA 
estimates that it takes sponsors and applicants approximately 8 hours 
to prepare a claim of 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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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15 (a) and (d)...............             247               2             494               8           3,952
25.40 (a) and (c)...............               2               1               2           3,400           6,800
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,752
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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), 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 25.30 or 
25.33 or an EA under 25.40. In 2011, FDA's Center for Veterinary 
Medicine has received approximately 698 claims for categorical 
exclusion as required under 25.15(a) and (d), and 10 EAs as required 
under 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates 
that approximately 70 respondents will submit an average of 10 
applications for categorical exclusion and 10 respondents will submit 
an average of 1 EA. FDA estimates that it takes sponsors/applicants 
approximately 3 hours to prepare a claim of categorical exclusion and 
an average of 2,160 hours to prepare an EA.

[[Page 59622]]



                         Table 5--Estimated Annual Reporting Burden for Animal Drugs \1\
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15 (a) and (d)...............              70              10             700               3           2,100
25.40 (a) and (c)...............              10               1              10           2,160          21,600
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          23,700
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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 Tobacco Products

    Under sections 905, 910, and 911 of the Federal Food, Drugs, and 
Cosmetic Act, premarket tobacco applications (PMTAs), applications for 
substantial equivalence (SEs), Exemption from SEs, and modified risk 
tobacco products must contain a claim for categorical exclusion under 
25.30 or 25.34 or an EA under 25.40. In 2011, FDA estimated it will 
receive approximately 20 PMTAs and supplements from 20 respondents, 150 
reports intended to demonstrate the SE of a new tobacco product from 
150 respondents, 500 exemption from SE requirements applications from 
500 respondents, and 3 modified risk Tobacco product applications from 
3 respondents for a total of 673 responses from 673 respondents. FDA 
estimates that there were 538 claims from 538 respondents for 
categorical exclusions as required under 25.15(a) and (d), and 135 EAs 
from 135 respondents as required under 25.40(a) and (c). Therefore, 
over the next 3 years, FDA estimates that approximately 538 respondents 
will submit an average of 1 application for categorical exclusion and 
135 respondents will submit an average of 1 EA. Based on FDA's 
experience and previous information provided by potential sponsors, FDA 
estimates that it takes approximately 12 hours to prepare a claim for a 
categorical exclusion and 12 hours to prepare an EA.

                       Table 6--Estimated Annual Reporting Burden for Tobacco Products \1\
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15 (a) and (d)...............             538               1             538              12           6,456
25.40 (a) and (c)...............             135               1             135              12           1,620
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           8,076
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                      Table 7--Estimated Annual Total Reporting Burden for All Centers \1\
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                                                     Number of                        Average
           CFR Section               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15 (a) and (d)...............           4,124  ..............          14,526  ..............         114,756
25.40 (a) and (c)...............             190  ..............             190  ..............          70,950
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         185,706
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23838 Filed 9-27-12; 8:45 am]
BILLING CODE 4160-01-P


