
[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Notices]
[Pages 15729-15732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06711]


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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; 
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 April 
25, 2016.

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.

[[Page 15730]]


FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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 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 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 a significant environmental impact. Section 25.40(a) and (c) 
specifies the content requirements for EAs for non-excluded 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 8, 2015 (80 FR 53807), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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 Sec. Sec.  312.23(a)(7)(iv)(c), 314.50(d)(1)(iii), and 
314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(c), 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. Annually, FDA receives 
approximately 3,677 INDs from 2,501 sponsors; 120 NDAs from 87 
applicants; 2,718 supplements to NDAs from 399 applicants; 9 biologic 
license applications (BLAs) from 8 applicants; 317 supplements to BLAs 
from 43 applicants; 1,475 ANDAs from 300 applicants; and 5,448 
supplements to ANDAs from 318 applicants. FDA estimates that it 
receives approximately 13,663 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.

                         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)................           3,416               4          13,664               8         109,312
25.40(a) and (c)................              11               1              11           3,400          37,400
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         146,712
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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. Annually, FDA receives approximately 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). 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

[[Page 15731]]

requestors approximately 8 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
                           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)...................................................              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 Sec.  814.20(b)(11) (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 2012 to 2014, FDA received an average of 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). FDA estimates that approximately 39 respondents 
will submit an average of 1 application for categorical exclusion 
annually. Based on information provided by 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                        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)................              39               1              39               6             234
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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

    Under 21 CFR 601.2(a), BLAs 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. Annually, FDA receives 
approximately 34 BLAs from 18 applicants, 801 BLA supplements to 
license applications from 156 applicants, 345 INDs from 256 sponsors, 1 
NDA from 1 applicant, 26 supplements to NDAs from 8 applicants, 1 ANDA 
from 1 applicant, 1 supplement to ANDAs from 1 applicant, 8 PMAs from 3 
applicants, and 33 PMA supplements from 16 applicants. FDA estimates 
that approximately 10 percent of these supplements would be submitted 
with a claim for categorical exclusion or an EA.
    FDA has received approximately 481 claims for categorical exclusion 
as required under Sec.  25.15(a) and (d) annually and 2 EAs as required 
under Sec.  25.40(a) and (c) annually. Therefore, 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 Sec.  25.40. Annually, 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). 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

[[Page 15732]]

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 Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387e, 387j, and 387k), product applications and 
supplements (PMTAs), SEs, Exemption from SEs, and modified risk tobacco 
products must contain a claim for categorical exclusion or an EA. In 
2015, FDA estimated it will receive approximately 5 premarket reviews 
of new tobacco PMTAs from 5 respondents, 509 reports intended to 
demonstrate the substantial equivalence of a new tobacco product (SEs) 
from 509 respondents, 15 exemptions from substantial equivalence 
requirements applications (SE Exemptions) from 15 respondents, and 3 
modified risk tobacco product applications (MRTPAs) from 3 respondents. 
FDA is not accepting claims for categorical exclusions at this time, 
and estimates that there will be 532 EAs from 532 respondents as 
required under Sec. Sec.  25.40(a) and (c). Therefore, over the next 3 
years, FDA estimates that approximately 532 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 MRTPA. Based on FDA's experience, 
previous information provided by potential sponsors 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.

                                           Table 6--Estimated Annual Reporting Burden for Tobacco Products \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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25.40(a) and (c)...................................................             532                1              532               80           42,560
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06711 Filed 3-23-16; 8:45 am]
 BILLING CODE 4164-01-P


