[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55484-55487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8025]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0105]


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.

DATES: Fax written comments on the collection of information by October 
23, 2006.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Liz Berbakos, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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)--
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 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 preparing and circulating to the public

[[Page 55485]]

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).
    In the Federal Register of March 29, 2006 (71 FR 15753), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions to which FDA received one comment. The comment 
said it supports the current FDA approach to assessing potential 
environmental impact under NEPA. However, the comment questioned 
whether one aspect of the collection of information is necessary for 
the proper performance of FDA's functions, including whether the 
information has practical utility, and contended that eliminating the 
collection of information would minimize the burden on respondents.
    Specifically, the comment suggested that FDA should ``eliminate 
unnecessary work'' related to requests for categorical exclusions for 
actions on certain investigational new drug applications (INDs). 
Section 25.31 lists classes of actions that are categorically excluded 
and, therefore, ordinarily do not require the preparation of an EA or 
an EIS. Section 25.31(e) lists an ``action on an IND'' as one of these 
classes of actions. The comment proposed that Sec.  25.31(e) be amended 
as follows: ``Action on INDs where the drug or biologic product is 
derived from wild plants or animals. Action on other types of INDs do 
not require a claim for a categorical exclusion.'' The comment proposed 
that categorical exclusions should be automatically granted for actions 
on INDs where the drug or biologic products are not derived from wild 
plants or animals.
    The comment proposed this amendment to Sec.  25.31(e) for the 
following reasons, each of which suggests that claims for categorical 
exclusion for action on an IND have little practical utility and 
amending Sec.  25.31(e) as proposed represents a way to minimize the 
burden of the collection of information:
    1. FDA's guidance document entitled ``Environmental Assessment of 
Human Drug and Biologics Applications'' (July 1998) states: ``INDs 
generally involve relatively small quantities of a drug or biologic 
product and treatment of a limited number of patients. Many INDs never 
result in the filing of an NDA or application for marketing approval of 
a biologic product, which would allow for the wide-spread commercial 
sale of the product. CDER and CBER will evaluate INDs on a case-by-case 
basis where the drug or biologic product is derived from wild plants or 
animals to determine whether the extraordinary circumstance provision 
in Sec.  25.21 is invoked.'' (See section III.C.3.b.ii of the guidance 
document).
    2. Pharmaceutical companies have been providing claims for 
categorical exclusion for action on an IND since the early 1990's for 
active pharmaceutical ingredients (APIs) in all therapeutic classes, 
and the companies have no indication that FDA has used these claims as 
the basis for denials pertinent to potential environmental impact as 
described under NEPA.
    3. Usage of an API under an IND is ``site limited and time 
bounded,'' indicating that ``the potential for patient excretion of an 
API to the environment is extremely limited.''
    4. The potential risk from pharmaceuticals in the environment 
pertains to long-term, chronic exposure, and usage of an API under an 
IND will not result in the type of exposure widely accepted as being of 
potential environmental concern. The comment also stated that prior to 
marketing approval of an API, FDA will have the opportunity to review 
potential environmental impact through its EA requirements.
    5. The comment concluded that amending Sec.  25.31(e) as proposed 
would have ``eliminated work on up to 1933 categorical exclusions 
(15,464 hours) for INDs in 2005 that ultimately had no practical 
utility.''
    FDA appreciates the comment requesting that Sec.  25.31(e) be 
amended so that categorical exclusions could be automatically granted 
for actions on INDs where the drug or biologic products are not derived 
from wild plants or animals. The purpose of the March 29, 2006, Federal 
Register notice and this notice, however, is to afford an opportunity 
for comment on the information collection requirements and burden 
estimates for part 25, and to request that OMB extend approval for that 
collection. Because the comment requests a rulemaking change, we have 
forwarded it to the office in each center that is responsible for the 
information collection requirements in part 25 so that the comment may 
be considered for any future amendments to the regulations.
    FDA estimates the burden of this collection of information as 
follows:

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 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.

                                             Table 1.--Estimated Annual Reporting Burden for Human Drugs\1\
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                                                                     Annual Frequency per      Total Annual
                21 CFR Section                  No. of Respondents         Response              Responses       Hours per Respondent     Total Hours
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25.15(a) and (d)                                              2,284                  4.32                 9,813                     8             78,504
25.40(a) and (c)                                                 11                     1                    11                 3,400             37,400
Total                                          ....................  ....................  ....................  ....................            115,904
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 55486]]

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 for Human Foods\1\
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                             No. of      Annual Frequency per   Total Annual      Hours per
     21 CFR Section        Respondents         Response           Responses      Respondent       Total Hours
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25.15(a) and (d)                     57                   1.4              80               3                240
25.40(a) and (c)                     31                   1.3              39             210              8,190
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 for Medical Devices\1\
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                                          Annual Frequency     Total Annual        Hours per
  21 CFR Section    No. of Respondents      per Response        Responses          Respondent       Total Hours
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25.15(a) and (d)                     47                  6                282                  1             282
25.40(a) and (c)                      0                  0                  0                  0               0
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.

                     Table 4.--Estimated Annual Reporting Burden for Biological Products\1\
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                       No. of       Annual Frequency     Total Annual
  21 CFR Section     Respondents      per Response        Responses      Hours per Respondent     Total Hours
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25.15(a) and (d)              459               1.45                666                     8              5,328
25.40(a) and (c)                2                  1                  2                 3,400              6,800
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), NADAs and 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, 
the 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.

[[Page 55487]]



                         Table 5.--Estimated Annual Reporting Burden for Animal Drugs\1\
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                                      Annual Frequency per     Total Annual        Hours per
21 CFR Section   No. of Respondents         Response            Responses          Respondent       Total Hours
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25.15(a) and                     134                   3.9                421                  8           3,368
 (d)
25.40(a) and                      12                   1.6                 14              2,160          30,240
 (c)
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: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8025 Filed 9-21-06; 8:45 am]
BILLING CODE 4160-01-S