
[Federal Register Volume 78, Number 34 (Wednesday, February 20, 2013)]
[Notices]
[Pages 11892-11895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 (the PRA).

DATES: Fax written comments on the collection of information by March 
22, 2013.

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 emailed 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: 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: 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--(OMB Control Number 0910-0322)--
Revision

    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. 4321-4327) 
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 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 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 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.
    In the Federal Register of September 28, 2012 (77 FR 59619), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments that were PRA related were 
received from one commenter.
    (Comment 1) The commenter indicated that FDA underestimates the 
hours required to complete an environmental assessment for tobacco 
products, and that FDA's 12 hours burden estimate per response is 
substantially underestimated. The commenter said, based on the 
commenter's experience, an environmental assessment for tobacco 
products should take approximately 80 hours to complete.
    (Response 1) FDA agrees with this comment. Upon further review of 
the number of hours required to complete an environmental assessment 
for tobacco products, FDA has determined that 12 hours is too low an 
estimate and has revised the burden estimate per response for 
completing an environmental assessment for tobacco products from 12 to 
80 hours. This revision was based upon revisiting this estimate with 
the Center for Tobacco Products staff and this comment. Rethinking the 
time to prepare an environmental assessment for tobacco products 
resulted in revising the burden per response to 80 hours.
    (Comment 2) The commenter also encouraged the Agency to establish 
categorical exclusions for environmental assessments for tobacco 
product submittals under section 905(j) of the

[[Page 11893]]

Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
387e(j)).
    (Response 2) FDA has decided to not establish categorical 
exclusions for tobacco products at this time.
    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)(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 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 will receive approximately 15,699 
claims for categorical exclusions as required under Sec.  25.15(a) and 
(d), and 10 EAs as required under Sec.  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 Sec.  25.30 or Sec.  25.32 or an EA 
under Sec.  25.40. In 2011, FDA received 97 industry submissions. FDA 
received an annual average of 42 claims of categorical exclusions as 
required under Sec.  25.15(a) and (d), and 33 EAs as required under 
Sec.  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
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................              42               1              42               8             336
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 Sec.  25.30 or Sec.  25.34 or an EA under Sec.  25.40. In 2011, 
FDA received approximately 52 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). 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.


[[Page 11894]]

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 (Sec.  312.23), NDAs 
(Sec.  314.50), ANDAs (Sec.  314.94), and PMAs (Sec.  814.20), must 
contain either a claim of categorical exclusion under Sec.  25.30 or 
Sec.  25.32 or an EA under Sec.  25.40. In 2011, FDA received 14 BLAs 
from 14 applicants, and 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 Sec.  25.15(a) and (d), and 2 
EAs as required under Sec.  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 Sec.  
25.30 or Sec.  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 Sec.  25.15(a) and (d), and 10 
EAs as required under Sec.  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.

                         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 FD&C Act (21 U.S.C. 387j 
and 387k), 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 
Sec.  25.30 or Sec.  25.34 or an EA under Sec.  25.40. When estimating 
the burden for tobacco products, FDA considered the environmental 
impacts associated with different applications. Specifically, 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 exemptions from SE 
requirements applications from 500 respondents, and 3 modified risk 
tobacco product applications from 3 respondents. FDA is also not 
accepting claims for categorical exclusions at this time, and estimates 
that there will be 135 EAs from 135 respondents as required under Sec.  
25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that 
approximately 135 respondents will submit an average of 1 application 
for environmental assessment. Part of the information in the EA will be 
developed while writing other parts of a PMTA, SE., exemption from SE, 
or modified risk tobacco product application. Based on FDA's 
experience, previous information provided by potential sponsors, 
information provided by a commenter to this collection of information, 
and knowledge that part of the EA information has already been produced 
in one of the tobacco product applications, FDA estimates that it takes 
approximately 80 hours to prepare an EA.

[[Page 11895]]



                       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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25.40(a) and (c)................             135               1             135              80          10,800
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,800
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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
         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)................           3,586  ..............          13,998  ..............         108,300
25.40(a) and (c)................             190  ..............             190  ..............          80,130
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         188,430
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03836 Filed 2-19-13; 8:45 am]
BILLING CODE 4160-01-P


