[Federal Register Volume 65, Number 49 (Monday, March 13, 2000)]
[Notices]
[Pages 13405-13408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0836]


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 requirements governing 
applications for FDA approval to market a new drug.

DATES: Submit written comments on the collection of information by May 
12, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (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: Karen Nelson, Office of Information 
Resources Management (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: (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 FDA's regulation ``Environmental Impact Considerations'' 
(part 25).
    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 at part 25. All applications or 
petitions requesting agency action require the submission of an 
Environmental Assessment (EA) or a claim of categorical exclusion. 
Section 25.15(a) and (d) specify the procedures for submitting to FDA a 
claim for a categorical exclusion (certain classes of FDA-regulated 
actions have little or no potential to cause significant environmental 
effects and are excluded from the requirements to prepare an EA or 
EIS). Section 25.40(a) and (c) specify the content requirements for 
EA's 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 (when 
not eligible for categorical exclusion) 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 Federal 
Register notice 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. When the agency finds that no 
significant environmental effects are expected, the agency prepares a 
Finding of No Significant Impact (FONSI).

I. Estimated Annual Reporting Burden for Human Drugs

    Under 21 CFR 312.23(a)(7)(e), 314.50(d)(1)(iii), and 
314.94(a)(9)(i), each investigational new drug

[[Page 13406]]

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 1998, FDA 
received 2,427 IND's from 1,874 sponsors, 129 NDA's from 80 applicants, 
2,500 supplements to NDA's from 238 applicants, 345 ANDA's from 101 
applicants, and 3,713 supplements to ANDA's from 165 applicants. FDA 
estimates that it receives approximately 9,094 claims for categorical 
exclusions as required under Sec. 25.15(a) and (d), and 20 EA's 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
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
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25.15(a) and (d)                    2,039               4.46        9,094               8          72,752
25.40(a) and (c)                       20               1              20           3,400          68,000
Total                                                                                             140,752
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. Estimated Annual Reporting Burden for Human Foods

    Under 21 CFR 71.1 and 170.39, food additive petitions, color 
additive petitions, and requests for exemption from regulation as a 
food additive must contain a claim of categorical exclusion under 
Sec. 25.30 or Sec. 25.32 or an EA under Sec. 25.40. In 1998, FDA 
received 57 food additive petitions, 9 color additive petitions, and 26 
threshold of regulation exemption requests. FDA estimates that it 
received approximately 80 claims of categorical exclusions as required 
under Sec. 25.15(a) and (d), and 12 EA's as required under 
Sec. 25.40(a) and (c). FDA estimates that it takes petitioners or 
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 Drugs \1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                       44               1.8             8.0             8             640
25.40(a) and (c)                       11               1.1            12             210           2,520
Total                                                                                              3,160
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The Food and Drug Administration Modernization Act of 1997 (FDAMA) 
(Public Law 105-115) amended section 409 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 348) to establish a premarket 
notification process as the primary method for authorizing a new use of 
a food additive that is a food contact substance. Section 409(h)(6) of 
the act defines a food contact substance as any substance intended for 
use as a component of materials used in manufacturing, packing, 
transporting, or holding food if such use is not intended to have any 
technical effect in food. Under the notification process, FDA must be 
notified at least 120 days prior to the marketing of a food contact 
substance. If FDA does not object within 120 days to the use of a food 
contact substance that is the subject of a notification, the substance 
may be legally marketed for the notified use. FDA expects that the 
majority of new uses of food contact substances that will be the 
subject of premarket notifications would previously have been regulated 
under the food additive petition process or exempted from the 
requirement of a regulation under the threshold of regulation process. 
FDA has provided in a separate Federal Register notice an opportunity 
for public comment on the collection of information associated with the 
premarket notification program, including environmental information 
requirements (64 FR 61648, November 12, 1999).

III. Estimated Annual Reporting Burden for Medical Devices

    Under 21 CFR part 814, premarket approvals (original PMA's and 
supplementals) must contain a claim for categorical exclusion under 
Sec. 25.30 or Sec. 25.31 or an EA under Sec. 25.40. In 1998, FDA 
received 568 claims (original PMA's and supplementals) for categorical 
exclusions as required under Sec. 25.15(a) and (d), and 0 EA's 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
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                       94               6             568               1             568
25.40(a) and (c)                        0               0               0               0               0

[[Page 13407]]

 
Total                                                                                                568
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

IV. Estimated Annual Reporting Burden for Biological Products

    Under 21 CFR 312.23(a)(7)(iv)(c) and 601.2(a), IND and biologics 
license applications must contain a claim for categorical exclusion 
under Sec. 25.30 or Sec. 25.31 or an EA under Sec. 25.40. In 1998, FDA 
received 492 IND's from 278 sponsors, 78 license applications from 20 
applicants, and 903 supplements to license applications from 190 
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 receives approximately 660 claims for 
categorical exclusion as required under Sec. 25.15(a) and (d), and 2 
EA's 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.

                     Table 4.--Estimated Annual Reporting Burden for Biological Products \1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                      317               2             660               8           5,280
25.40(a) and (c)                        2               1               2           3,400           6,800
Total                                                                                             12,080
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

V. Estimated Annual Reporting Burden for Animal Drugs

    Under 21 CFR 514.1(b)(14) new animal drug applications (NADA's) and 
abbreviated new animal drug applications (ANADA's), 514.8(a)(1) 
supplemental NADA's and ANADA's, 511.1(b)(10) investigational new 
animal drug applications (INADA's), 570.35(c)(1)(viii) generally 
recognized as safe (GRAS) affirmation petitions, and 571.1(c) food 
additive petitions must contain a claim for categorical exclusion under 
Sec. 25.30 or Sec. 25.31 or an EA under Sec. 25.40. Since the last OMB 
Approval of the subject collections of information, the Center for 
Veterinary Medicine has received approximately 545 claims for 
categorical exclusions as required under Sec. 25.15(a) and (d), and 32 
EA's 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 approximately 2,160 hours to prepare an EA.

                        Table 5.--Estimated Annual Reporting Burden for Animal Drugs \1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                      194               2.8           545               8           4,360
25.40(a) and (c)                       29               1.1            32           2,160          69,120
Total                                                                                             73,480
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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 burden for the Environmental Impact Considerations--Part 25 
are as follows:

                  Table 6.--Entire Total Estimated Annual Reporting Burden for All Centers \1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
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25.15(a) and ((d)                   2,688              17.06       10,875              33          83,600
25.40(a) and (c)                       62               4.02           66           9,170         146,440
Total                               2,750              21.08       10,941           9,203         230,040
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\1\ There are no capital costs or operating and maintenance cost associated with this collection of information.



[[Page 13408]]

    Dated: March 6, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-5969 Filed 3-10-00; 8:45 am]
BILLING CODE 4160-01-F