[Federal Register Volume 68, Number 123 (Thursday, June 26, 2003)]
[Notices]
[Pages 38063-38065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16107]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0085]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Environmental Impact Considerations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below 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 July 
28, 2003.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. 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: Fumie Yokota, Desk 
Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (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--Part 25 (21 CFR Part 25) (OMB 
Control Number 0910-0322)--Extension

    FDA is requesting OMB approval for the reporting requirements 
contained in the FDA regulation entitled ``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 at 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 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.

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 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 2002, FDA received 2,374 
INDs from 1,809 sponsors, 109 NDAs from 79 applicants, 2,575 
supplements to NDAs from 276 applicants, 392 ANDAs from 107 applicants, 
and 3,343 supplements to ANDAs from 222

[[Page 38064]]

applicants. FDA estimates that it receives approximately 8,771 claims 
for categorical exclusions as required under Sec.  25.15(a) and (d), 
and 22 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\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                    2,031               4.32        8,773               8          70,184
25.40(a) and (c)                       22               1              22           3,400          74,800
Total                             ..............  ..............  ..............  ..............  144,984
----------------------------------------------------------------------------------------------------------------
\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 for exemption from 
regulation as a food additive, and submission of a premarket 
notification for a food contact substance must contain a claim of 
categorical exclusion under Sec.  25.30 or Sec.  25.32 or an EA under 
Sec.  25.40. In 2002, FDA received 12 food additive petitions and 106 
food contact substance notifications. FDA estimates that it received 
approximately 87 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 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 Foods\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                       56               1.6            89               4             356
25.40(a) and (c)                       18               1.7            31             210           6,510
Total                             ..............  ..............  ..............  ..............    6,866
----------------------------------------------------------------------------------------------------------------
\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 (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 1998, 
FDA received 568 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\
----------------------------------------------------------------------------------------------------------------
                                                      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             564               1             564
25.40(a) and (c)                        0               0               0               0               0
Total                             ..............  ..............  ..............  ..............      564
----------------------------------------------------------------------------------------------------------------
\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 2001, FDA received 535 INDs from 376 sponsors, 80 BLAs from 22 
applicants, and 837 BLA supplements to license applications from 168 
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 699 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.

[[Page 38065]]



                     Table 4.--Estimated Annual Reporting Burden for Biological Products\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                      415               1.68          699               8           5,592
25.40(a) and (c)                        2               1               2           3,400           6,800
Total                             ..............  ..............  ..............  ..............   12,392
----------------------------------------------------------------------------------------------------------------
\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 Sec.  514.1(b)(14) (21 CFR 514.1(b)(14)), new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs), Sec.  514.8(a)(1) supplemental NADAs and ANADAs, 21 CFR 
511.1(b)(10) investigational new animal drug applications (INADs), 
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.  25.33 or an EA 
under Sec.  25.40. Since the last OMB approval of these collections of 
information, FDA's Center of Veterinary Medicine has received 
approximately 547 claims for categorical exclusion as required under 
Sec.  25.15(a) and (d), and 19 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.

                         Table 5.--Estimated Annual Reporting Burden for Animal Drugs\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                      139               3.9           542               8           4,336
25.40(a) and (c)                       14               1.4            19           2,160          41,040
Total                             ..............  ..............  ..............  ..............   45,376
----------------------------------------------------------------------------------------------------------------
\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 is 
as follows:

                         Table 6.--Estimated Annual Reporting Burden for All Centers\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per     Total Burden
                                    Respondents      Response        Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)                    2,735              17.5        10,768              29          81,032
25.40(a) and (c)                       56               5.1            74           9,199         129,150
Total                             ..............  ..............  ..............  ..............  210,182
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    In the Federal Register of March 17, 2003 (68 FR 12702), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

    Dated: June 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16107 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S