**Supporting Statement**

**Environmental Impact Considerations - 21 CFR Part 25 ‑**

**(OMB Control Number 0910‑0322)**

**Docket Number 2003N-0085**

A. **[Justification]{.underline}**

**1. [Circumstances of Information Collection]{.underline}**

**FDA is requesting OMB approval for the reporting requirements
contained in the FDA regulation \"Environmental Impact Considerations\"
(21 CFR 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.**

**The FDA NEPA regulations are at 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. Sections 25.15(a) and (d) specify the procedures for
submitting to FDA a claim for a categorical exclusion. Extraordinary
circumstances (section 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. Sections 25.40(a) and (c) specify 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 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. 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 agencys 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).**

**2. [Purpose and Use of Information]{.underline}**

**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 notices also filed for comment at the
Environmental Protection Agency (EPA). If the agency finds that no
significant environmental effects are expected, the agency prepares a
finding of no significant impact (FONSI).**

**3. [Use of Improved Information Technology]{.underline}**

**For human drugs, the submissions under 21 CFR part 25 are part of an
application for marketing. Some of the steps that FDA has taken to
facilitate the electronic submission of marketing applications
include:**

**[Electronic Regulatory Submissions for Archive]{.underline}. The Food
and Drug Administration Modernization Act of 1997 (FDAMA), along with
the Prescription Drug User Fee Act (PDUFA) II reauthorization, mandate
that the Agency shall develop and update its information management
infrastructure to allow, by fiscal year 2002, the paperless receipt and
processing of INDs and human drug applications, as defined in PDUFA, and
related submissions. Moving an information-intensive activity, such as
drug regulatory review, from a paper-based to an electronic environment
will provide a number of benefits. This is true simply from the
perspective of generating, handling, and storing the huge volumes of
paper commonly associated with applications. In general, these paper
applications (often containing 100s of volumes) are submitted with
several copies, a process that can take several days longer than
preparation of a corresponding electronic submission, which the Center
can easily reproduce. Preparation of applications in electronic form
results in direct cost savings related to materials, supplies, and paper
handling logistics (i.e., labor, facilities). However, this is expected
to be only a small portion of the potential savings. The most
substantial burden reduction may not be in information recording,
reporting, and record-keeping, but in the flexibility, efficiency,
speed, and ease of filing required information that will result in cost
savings to regulated industry, as well as FDA.**

**Guidance documents relating to electronic submissions that are
published or planned are as follows:**

**Providing Regulatory Submissions in Electronic Format Prescription
Drug Advertising and Promotional Labeling**

**Promotional material and drug advertising guidance**

**Providing Regulatory Submissions in Electronic Format**
**Post-marketing Expedited Safety Reports**

**Abbreviated New Drug Application guidance**

**Post-marketing Safety Reports.**

**Electronic submission of Investigational New Drug (IND)
Applications.**

**Promotional material and drug advertising guidance.**

**Electronic submission of Drug Master Files (DMF) and Annual Reports.**

**Electronic submission of IND and DMF are pending work on the
electronic common technical document at the International Conference on
Harmonisation.**

**For FY 2001, CDER has continued to expanded the Electronic Document
Room to manage the receipt and handling of full electronic NDAs.
Approximately 71% of original NDAs received by CDER in FY 2001 included
sections that conform to the electronic submission guidance. There were
1185 electronic submissions, which represents a 134% increase in the
number of**

**electronically submitted NDAs in FY 2001 over FY 2000. At the end of
FY 2001, the EDR housed electronic submissions for 460 NDAs, a 69%
increase compared to the 271 NDAs at the end of FY 2000. The first
quarter of FY 2002 continues to show increases in the number of
electronic submissions. At the end of the first quarter FY 2002, the EDR
has already received electronic submissions for an additional 100 NDAs
making a total of 560 electronically submitted NDAs. By the fourth
quarter of FY 2002, CDER expects to accommodate Periodic Safety reports,
and Annual Reports.**

**In FY 2001, CDER developed and implemented an Adverse Event Reporting
System (AERS) electronic submission module that is currently accepting
the electronic submission of AERS 15-day reports without attachments.
This effort involves the receipt and physical processing of electronic
adverse event reports and development of software to electronically
extract data from the reports and insert it into the AERS database. In
the near future, functionality will be provided to accept periodic
reports without attachments. The electronic submission software is also
being modified to accept submissions in the new XML Data Type Definition
(DTD) format.**

**[Secure E-Mail]{.underline}. During a drugs development cycle,
communications between CDER review divisions and the company developing
the drug is sensitive and proprietary. Prior to using secure E-mail,
CDER methods of** **secure communication included U.S. mail, courier,
telephone, and facsimile. These methods, some of which are not entirely
secure, can be inefficient or time consuming, and can significantly
contribute to the overall length of time involved in the drug review
process. The widespread use of E-mail across the Internet offers a more
efficient and scaleable means of information exchange. However, security
risks of communicating over the Internet are well known. In addition,
with the increasing threat of terrorism, the internet is one of the
easiest and most often used port of entries for Hackers and other
intruders who wish to gain access to confidential information, disrupt
and destroy our IT applications and infrastructure. The information
technology industry is answering security concerns by developing new
standards of cryptographic techniques, E-mail formats, authentication
algorithms, and other related aspects of secure communications. After
conducting a formal requirements study for secure E-mail which led to
the selection of Worldtalk Corporations WorldSecure Server as the base
pilot platform. CDER completed a pilot, the final system design and
implemented the production system in October of 1999. The system is
currently installed on all CDER PCs and is used by our reviewers to
communicate with over 15 companies and more than 150 individuals in
those companies. The system also provides virus scanning and extensive
E-mail filtering capabilities. The Secure Electronic Mail System,
ensures that all e-mail sent by CDER employees to regulated industry,
and all mail received from regulated industry members who posses secure
mail capabilities is encrypted. It is vital that we protect the security
of our e-mail system to the fullest extent possible. Terrorists may
attempt to intercept drug approval or other forms of sensitive
information transmitted to and from industry. This information can than
be used by potential terrorists groups to plan attacks on the American
public or sabotage our nations drug supplies. The implementation of
encryption software/hardware such as Secured Mail, ensures the safety
and security of CDERs important IT resources and data.**

**[ICH M2.]{.underline} FDA is involved in several standards-related
projects that impact the format and content of regulatory submissions.
FDA plays an active role in the development of standards and guidelines
as issued by organizations such as the National Institute of Standards
and Technology (NIST), the International Organization for
Standardization (ISO), and the US Pharmacopeia. A major standards
development activity in which the Agency actively participates is the
International Conference on Harmonization (ICH), a collaborative effort
involving the regulatory authorities of Europe, Japan and the United
States and experts from the pharmaceutical industry in those three
regions. The purpose of ICH is to recommend ways to achieve greater
harmonization in the interpretation and application of technical
guidelines and requirements to curtail regulatory duplication by working
towards a common worldwide drug and biologic registration package.**

**The activities within the ERSR program are influenced most by the ICH
M2 Expert Working Group (EWG) which focuses on Electronic Standards for
Transmission of Regulatory Information. The goal of M2 is to identify,
evaluate, and recommend appropriate and relevant standards to facilitate
the electronic transfer of regulatory information between industry
authorities and among regulatory agencies. The FDA representative from
CDER serves as the Rapporteur for the M2 EWG and the FDAs
representatives from CBER and OIRM are deputy topic leaders. The M2 EWG
maintains a series of recommendations for facilitating electronic
communications, including recommendations for physical media,
networking, secure EDI transmission over the Internet, and electronic
document format. FDA is also active in the ICH M4 EWG, which focuses on
the Common Technical Document (CTD) for the technical content of
sections of the NDA.**

**Throughout the remainder of the PDUFA II period, CBER , CDER and OIRM
will continue to play active roles in the standards development
activities of the ICH and other standards organizations and these
standards will be implemented, where appropriate, within the ERSR
Program.**

**4. [Efforts to Identify Duplication]{.underline}**

**FDA avoids duplication by encouraging applicants to reference in their
environmental documents data and information presented in other
documents that are available to FDA and the public (21 CFR 25.40(d)).
FDA intends to focus environmental reviews on the use and disposal from
use of FDA regulated articles. Because FDA actively works to ensure the
consistency of its protocols with those prescribed by EPA, the American
Society for Testing and Materials (ASTM), and Organization for Economic
Co-operation and Development (OECD), FDA avoids unnecessary duplication
of environmental testing. Thus, environmental testing that has already
been performed will not have to be repeated by a different protocol when
applicants move from one regulatory agency to another and from one
country to another for approvals of the same chemical substance.**

**Where possible, existing data are used by FDA in evaluating the
environmental impact of an industry-sponsored application or petition.
To the extent publicly available, data in FDA files may be
cross-referenced, data available in the scientific literature may be
submitted, and data gathered for other government agencies, such as EPA,
may be used in support of the environmental review of an application to
FDA.**

**FDA recognizes that there are instances where the same substance may
be the subject of separate environmental analyses by another agency, for
example by EPA. FDA has determined that separate environmental review is
not necessary for FDA approval of a food additive petition or FDA
granting a request for an exemption from regulations as a food additive
if the substance is already registered by EPA under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the same use
requested in the petition. Although both agencies have worked to
eliminate duplication of effort, applications submitted to FDA sometimes
involve a different use of a chemical substance than the use(s) reviewed
by EPA and the patterns of environmental introduction often vary.
Therefore, in some circumstances, a document prepared by FDA or another
agency may not suffice as the NEPA document.**

**5. [Involvement of Small Entities]{.underline}**

**For both large and small entities, FDA has identified the types of
information necessary to review the environmental impact of a new
product and, where possible, provides case-by case guidance on the
specific types of information required for a particular action. FDA does
not have the resources to perform a firms environmental studies and the
information gathering necessary for the evaluation of a new product.
However, small manufacturers may request help in applying for approval
from the FDA Office of Small Manufacturer\'s Assistance. Because FDA has
identified categories of actions that are categorically excluded from
the requirement to prepare an EA and EIS, fewer EA\'s and EIS\'s are
likely to be required from small businesses.**

**6. [Consequences If Information Collected Less
Frequently]{.underline}**

**Industry-sponsored applications and petitions are submitted to obtain
permission to market a new product or to expand the usage of a currently
regulated product. If the frequency of collection for environmental
impact data were reduced, the agency could not assess the environmental
impact of approving applications. Failure to take environmental factors
into account in the agency decision making would leave the agency
susceptible to court challenge and may result in unnecessary delays in
the approval for marketing of products.**

**7. [Consistencies with Guidelines in 5 CFR 1320.5(d)(2)]{.underline}**

**Data collection for applications is consistent with these
guidelines.**

**8. [Consultations Outside the Agency]{.underline}**

**FDA proposed revisions to 21 CFR part 25 in the Federal Register of
April, 3, 1996. FDA received comments on the proposed rule from 13
manufacturers, professional associations, environmental groups,
academics, environmental consultants, and the EPA. Through notification
in the Federal Register on October 22, 1996, the agency sought comments
on the categorical exclusions for which the information was provided.
Four additional comments were submitted as a result of the reopening of
the comment period. In the Federal Register of March 17, 2003, FDA
published a notice requesting comments on this collection of
information. No comments were received.**

**9. [Remuneration of Respondents]{.underline}**

**FDA has not provided and has no intention to provide any payment or
gift to respondents under the revisions of part 25.**

**10. [Assurance of Confidentiality]{.underline}**

**NEPA requires that EA\'s and EIS\'s be made available for public
review. However, 21 CFR 25.50(b) recognizes that FDA actions involving
investigations, review, and approval of applications and premarket
notifications for human drugs, animal drugs, biologic products, and
devices are protected from disclosure under the Trade Secret Act (TSA),
the Federal Food, Drug, and Cosmetic Act (FFDCA), and 21 CFR part 20.
Additionally, under 21 CFR 25.51 (a), data constituting trade secrets or
confidential information under the TSA or the FFDCA must not be included
in the portion of environmental documents that is made public. Thus,
environmental information will be made available to the public to the
extent permitted.**

**11. [Questions of a Sensitive Nature]{.underline}**

**There are no questions of a sensitive nature in the environmental
impact requirements.**

**12. [Estimates of Annualized Hour Burden]{.underline}**

**[Estimated annual reporting burden for human drugs]{.underline}**

**Under 21 CFR 312.23(a)(7)(iv)(*e*), 21 CFR 314.50(d)(1)(iii), and 21
CFR 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** **25.30 or 25.31
or an EA under** **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 applicants. FDA estimates that it receives approximately
8771 claims for categorical exclusions as required under** **25.15(a)
and (d), and 22 Eas as required under** **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 3400 hours to prepare an
EA.**

+-----------+-----------+-----------+-----------+-----------+-----------+
| **        |           |           |           |           |           |
| Estimated |           |           |           |           |           |
| Annual    |           |           |           |           |           |
| Reporting |           |           |           |           |           |
| Burden    |           |           |           |           |           |
| for Human |           |           |           |           |           |
| Drugs**   |           |           |           |           |           |
+===========+===========+===========+===========+===========+===========+
| **CFR**   | **Number  | **Annual  | **Total   | **Hours   | **Total   |
|           | of        | Frequency | Annual    | per       | Burden    |
| **        | Resp      | per       | Re        | R         | Hours**   |
| Section** | ondents** | R         | sponses** | esponse** |           |
|           |           | esponse** |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.15   | **2031**  | **4.32**  | **8,773** | **8**     | *         |
| (a) &     |           |           |           |           | *70,184** |
| (d)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.40   | **22**    | **1**     | **22**    | **3400**  | *         |
| (a) &     |           |           |           |           | *74,800** |
| (c)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **Total** |           |           |           |           | **        |
|           |           |           |           |           | 144,984** |
+-----------+-----------+-----------+-----------+-----------+-----------+

**There are no capital costs or operating and maintenance costs
associated with this collection of information.**

**[Estimated annual reporting burden for human foods]{.underline}**

**Under 21 CFR 171.1, 21 CFR 71.1, 21 CFR 170.39, and 21 CFR 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 (PMN) must contain a
claim of categorical exclusion under** **25.30 or 25.32 or an EA under**
**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**
**25.15(a) and (d), and 31 EAs as required under** **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.**

+-----------+-----------+-----------+-----------+-----------+-----------+
| **        |           |           |           |           |           |
| Estimated |           |           |           |           |           |
| Annual    |           |           |           |           |           |
| Reporting |           |           |           |           |           |
| Burden    |           |           |           |           |           |
| for Human |           |           |           |           |           |
| Foods**   |           |           |           |           |           |
+===========+===========+===========+===========+===========+===========+
| **CFR**   | **Number  | **Annual  | **Total   | **Hours   | **Total   |
|           | of        | Frequency | Annual    | per       | Burden    |
| **        | Resp      | per       | Re        | R         | Hours**   |
| Section** | ondents** | R         | sponses** | esponse** |           |
|           |           | esponse** |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.15   | **56**    | **1.6**   | **89**    | **4**     | **358**   |
| (a) &     |           |           |           |           |           |
| (d)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.40   | **18**    | **1.7**   | **31**    | **210**   | **6510**  |
| (a) &     |           |           |           |           |           |
| (c)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **Total** |           |           |           |           | **6866**  |
+-----------+-----------+-----------+-----------+-----------+-----------+

**There are no capital costs or operating and maintenance costs
associated with this collection of information.**

**[Estimated annual reporting burden for medical devices]{.underline}**

**Under 21 CFR 814.20(b)(11), pre-market approvals (original PMAs and
supplements) must contain a claim for categorical exclusion under**
**25.30 or 25.34 or an environmental assessment under** **25.40. In
1998, FDA received 568 claims (original PMAs and supplements) for
categorical exclusions as required under** **25.15(a) and (d), and 0
(zero) EAs as required under** **25.40(a) and (c). Based on information
provided by less than 10 sponsors, FDA estimates that it takes
approximately less than one hour to prepare a claim for a categorical
exclusion and an unknown number of hours to prepare an EA.**

+-----------+-----------+-----------+-----------+-----------+-----------+
| **        |           |           |           |           |           |
| Estimated |           |           |           |           |           |
| Annual    |           |           |           |           |           |
| Reporting |           |           |           |           |           |
| Burden    |           |           |           |           |           |
| for       |           |           |           |           |           |
| Medical   |           |           |           |           |           |
| Devices** |           |           |           |           |           |
+===========+===========+===========+===========+===========+===========+
| **CFR**   | **Number  | **Annual  | **Total   | **Hours   | **Total   |
|           | of        | Frequency | Annual    | per       | Burden    |
| **        | Resp      | per       | Re        | R         | Hours**   |
| Section** | ondents** | R         | sponses** | esponse** |           |
|           |           | esponse** |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.15   | **94**    | **6**     | **564**   | **1**     | **564**   |
| (a) &     |           |           |           |           |           |
| (d)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.40   | **0**     | **0**     | **0**     | **0**     | **0**     |
| (a) &     |           |           |           |           |           |
| (c)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **Total** |           |           |           |           | **564**   |
+-----------+-----------+-----------+-----------+-----------+-----------+

**There are no capital costs or operating and maintenance costs
associated with this collection of information.**

**[Estimated annual reporting burden for biological
products]{.underline}**

**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** **25.30 or 25.31 or an EA under** **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% 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** **25.15(a) and (d), and 2 EAs
as required under** **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 3400 hours to prepare an EA for a biological product.**

+-----------+-----------+-----------+-----------+-----------+-----------+
| **        |           |           |           |           |           |
| Estimated |           |           |           |           |           |
| Annual    |           |           |           |           |           |
| Reporting |           |           |           |           |           |
| Burden    |           |           |           |           |           |
| for       |           |           |           |           |           |
| B         |           |           |           |           |           |
| iological |           |           |           |           |           |
| P         |           |           |           |           |           |
| roducts** |           |           |           |           |           |
+===========+===========+===========+===========+===========+===========+
| **CFR**   | **Number  | **Annual  | **Total   | **Hours   | **Total   |
|           | of        | Frequency | Annual    | per       | Burden    |
| **        | Resp      | per       | Re        | R         | Hours**   |
| Section** | ondents** | R         | sponses** | esponse** |           |
|           |           | esponse** |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.15   | **415**   | **1.68**  | **697**   | **8**     | **5576**  |
| (a) &     |           |           |           |           |           |
| (d)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.40   | **2**     | **1**     | **2**     | **3400**  | **6800**  |
| (a) &     |           |           |           |           |           |
| (c)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **Total** |           |           |           |           | *         |
|           |           |           |           |           | *12,376** |
+-----------+-----------+-----------+-----------+-----------+-----------+

**There are no capital costs or operating and maintenance costs
associated with this collection of information.**

**[Estimated annual reporting burden for animal drugs]{.underline}**

**Under 21 CFR** **514.1(b)(14) new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs),** **514.8(a)(1)
supplemental NADAs and ANADAs,** **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** **25.30 or 25.33 or an EA under** **25.40. Since the last OMB
approval of these collections of information, the Center of Veterinary
Medicine (CVM) has received approximately 547 claims for categorical
exclusion as required under** **25.15(a) and (d), and 19 EAs as required
under** **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 2160 hours
to prepare an EA.**

+-----------+-----------+-----------+-----------+-----------+-----------+
| **        |           |           |           |           |           |
| Estimated |           |           |           |           |           |
| Annual    |           |           |           |           |           |
| Reporting |           |           |           |           |           |
| Burden    |           |           |           |           |           |
| for       |           |           |           |           |           |
| Animal    |           |           |           |           |           |
| Drugs**   |           |           |           |           |           |
+===========+===========+===========+===========+===========+===========+
| **CFR**   | **Number  | **Annual  | **Total   | **Hours   | **Total   |
|           | of        | Frequency | Annual    | per       | Burden    |
| **        | Resp      | per       | Re        | R         | Hours**   |
| Section** | ondents** | R         | sponses** | esponse** |           |
|           |           | esponse** |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.15   | **139**   | **3.9**   | **542**   | **8**     | **4,336** |
| (a) &     |           |           |           |           |           |
| (d)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **25.40   | **14**    | **1.4**   | **19**    | **2,160** | *         |
| (a) &     |           |           |           |           | *41,040** |
| (c)**     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **Total** |           |           |           |           | *         |
|           |           |           |           |           | *45,376** |
+-----------+-----------+-----------+-----------+-----------+-----------+

**There are no capital costs or operating and maintenance costs
associated with this collection of information.**

**Based on the above information, FDA estimates that the combined burden
for the Environmental Impact Considerations - Part 25 (21 CFR Part 25)
is as follows:**

+-----------+---------+----------+-------------+---------+-----------+
| **Entire  |         |          |             |         |           |
| Total     |         |          |             |         |           |
| Estimated |         |          |             |         |           |
| Annual    |         |          |             |         |           |
| Reporting |         |          |             |         |           |
| Burden**  |         |          |             |         |           |
|           |         |          |             |         |           |
| **for All |         |          |             |         |           |
| Centers** |         |          |             |         |           |
+===========+=========+==========+=============+=========+===========+
| **CFR     | *       | **Annual | **Total     | **Hours | **Total   |
| Section** | *Number | F        | Annual      | per     | Burden    |
|           | of      | requency | Responses** | Res     | Hours**   |
|           | Respon  | per      |             | ponse** |           |
|           | dents** | Re       |             |         |           |
|           |         | sponse** |             |         |           |
+-----------+---------+----------+-------------+---------+-----------+
| **        | **      | **17.5** | **10,674**  | **29**  | *         |
| 25.15(a)& | 2,735** |          |             |         | *81,032** |
| ((d)**    |         |          |             |         |           |
+-----------+---------+----------+-------------+---------+-----------+
| **25.40   | **56**  | **5.1**  | **74**      | **      | **        |
| (a)&(c)** |         |          |             | 9,170** | 129,150** |
+-----------+---------+----------+-------------+---------+-----------+
| **Total** |         |          |             |         | **        |
|           |         |          |             |         | 210,182** |
+-----------+---------+----------+-------------+---------+-----------+

**There are no capital costs or operating and maintenance with this
collection of information**

**13. [Estimates of Annualized Cost Burden to Respondents]{.underline}**

**FDA\'s Economics Staff estimates the average industry wage rate of
\$50.00 per hour for preparing and submitting the information collection
requirements associated with marketing applications. Based on a total
industry burden of 164,786 hours, the annualized cost burden to
respondents would be \$ 8,239,300.**

**14. [Estimates of Annualized Cost Burden to the
Government]{.underline}**

**FDA estimates a total of 5 FTEs are devoted to the review of
submissions associated with 21 CFR part 25. Based on an estimate of
\$100,000 per FTE, the annualized cost burden to FDA would be
\$500,000.**

**15. [Changes in Burden]{.underline}**

**The revised burden estimates are the result of the average number of
claims for categorical exclusions and EAs submitted over the past few
years.**

**16. [Time Schedule, Publication, and Analysis Plans]{.underline}**

**FDA does not intend to publish tabulated results of the information
collection requirements that are imposed by 21 CFR part 25.**

**17. [Displaying of OMB Approval Date]{.underline}**

> **There are no forms associated with this collection.**

**18. [Exception to the Certification Statement - Item 19]{.underline}**

**There are no exceptions to the \"Certification for Paperwork Reduction
Act Submissions\" in item 19 of OMB Form 83-I.**

**PAPERWORK REDUCTION ACT SUBMISSION**

+----------------------------------+-----------------------------------+
| **Please read the instructions   |                                   |
| before completing this form. For |                                   |
| additional forms or assistance   |                                   |
| in completing this form, contact |                                   |
| your agency\'s Paperwork         |                                   |
| Clearance Officer. Send two      |                                   |
| copies of this form, the         |                                   |
| collection instrument to be      |                                   |
| reviewed, the supporting         |                                   |
| statement, and any additional    |                                   |
| documentation to: Office of      |                                   |
| Information and Regulatory       |                                   |
| Affairs, Office of Management    |                                   |
| and Budget, Docket Library, Room |                                   |
| 10102, 725 17th Street NW,       |                                   |
| Washington, DC 20503.**          |                                   |
+----------------------------------+-----------------------------------+
| 1\. Agency/Subagency originating | 2\. OMB control number b. \[ \]   |
| request                          | None                              |
|                                  |                                   |
| FDA                              | a\. [0910]{.underline} -          |
|                                  | [0322]{.underline}                |
|                                  | [0910]{.underline}                |
+----------------------------------+-----------------------------------+
| 3\. Type of information          | 4\. Type of review requested      |
| collection (*check one*)         | (*check one*)                     |
|                                  |                                   |
| a\. \[ \] New Collection         | a\. \[X \] Regular submission     |
|                                  |                                   |
| b\. \[ \] Revision of a          | b\. \[ \] Emergency - Approval    |
| currently approved collection    | requested by [/ /]{.underline}    |
|                                  |                                   |
| c\. \[X \] Extension of a        | c\. \[ \] Delegated               |
| currently approved collection    |                                   |
|                                  |                                   |
| d\. \[ \] Reinstatement, without |                                   |
| change, of a previously approved |                                   |
|                                  |                                   |
| collection for which approval    |                                   |
| has expired                      |                                   |
|                                  |                                   |
| e\. \[ \] Reinstatement, with    |                                   |
| change, of a previously approved |                                   |
|                                  |                                   |
| collection for which approval    |                                   |
| has expired                      |                                   |
|                                  |                                   |
| f\. \[ \] Existing collection in |                                   |
| use without an OMB control       |                                   |
| number                           |                                   |
|                                  |                                   |
| For b-f, note Item A2 of         |                                   |
| Supporting Statement             |                                   |
| instructions                     |                                   |
+----------------------------------+-----------------------------------+
|                                  | 5\. Small entities                |
|                                  |                                   |
|                                  | Will this information collection  |
|                                  | have a significant economic       |
|                                  | impact on a substantial number of |
|                                  | small entities? \[ \] Yes \[ \]   |
|                                  | No                                |
+----------------------------------+-----------------------------------+
|                                  | 6\. Requested expiration date     |
|                                  |                                   |
|                                  | a\. \[X \] Three years from       |
|                                  | approval date b. \[ \] Other      |
|                                  | Specify: [/]{.underline}          |
+----------------------------------+-----------------------------------+
| 7\. Title **21 CFR 25 -          |                                   |
| Environmental Impact             |                                   |
| Considerations**                 |                                   |
+----------------------------------+-----------------------------------+
| 8\. Agency form number(s) (*if   |                                   |
| applicable*)                     |                                   |
+----------------------------------+-----------------------------------+
| 9\. Keywords NEPA, Environmental |                                   |
| Impact Statement, Environmental  |                                   |
| Assessment, Categorical          |                                   |
| Exclusion                        |                                   |
+----------------------------------+-----------------------------------+
| 10\. Abstract                    |                                   |
|                                  |                                   |
| **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.**        |                                   |
+----------------------------------+-----------------------------------+
| 11\. Affected public (*Mark      | 12\. Obligation to respond        |
| primary with \"P\" and all       | (*check one*)                     |
| others that apply with \"x\")*   |                                   |
|                                  | a\. \[ \] Voluntary               |
| a\. Individuals or households d. |                                   |
| Farms                            | b\. \[ \] Required to obtain or   |
|                                  | retain benefits                   |
| b\. [x]{.underline} Business or  |                                   |
| other for-profit e. Federal      | c\. \[x \] Mandatory              |
| Government                       |                                   |
|                                  |                                   |
| c\. Not-for-profit institutions  |                                   |
| f. State, Local or Tribal        |                                   |
| Government                       |                                   |
+----------------------------------+-----------------------------------+
| 13\. Annual recordkeeping and    | 14\. Annual reporting and         |
| reporting burden                 | recordkeeping cost burden *(in    |
|                                  | thousands of dollars)*            |
| a\. Number of respondents        |                                   |
| [2,791]{.underline}              | a\. Total annualized              |
|                                  | capital/startup costs             |
| b\. Total annual responses       | [0]{.underline}                   |
| [10,748]{.underline}             |                                   |
|                                  | b\. Total annual costs (O&M)      |
| 1\. Percentage of these          | [0]{.underline}                   |
| responses                        |                                   |
|                                  | c\. Total annualized cost         |
| collected electronically         | requested [0]{.underline}         |
| [0]{.underline} %                |                                   |
|                                  | d\. Current OMB inventory         |
| c\. Total annual hours requested | [0]{.underline}                   |
| [210,182]{.underline}            |                                   |
|                                  | e\. Difference [0]{.underline}    |
| d\. Current OMB inventory [230,  |                                   |
| 040]{.underline}                 | f\. Explanation of difference     |
|                                  |                                   |
| e\. Difference                   | 1\. Program change                |
| [19,860]{.underline}             |                                   |
|                                  | 2\. Adjustment                    |
| f\. Explanation of difference    |                                   |
|                                  |                                   |
| 1\. Program change               |                                   |
|                                  |                                   |
| 2\. Adjustment                   |                                   |
| [19,860]{.underline}             |                                   |
+----------------------------------+-----------------------------------+
| 15\. Purpose of information      | 16\. Frequency of recordkeeping   |
| collection (*Mark primary with   | or reporting *(check all that     |
| \"P\" and all others that apply  | apply)*                           |
| with \"X\"*)                     |                                   |
|                                  | a\. \[ \] Recordkeeping b. \[ \]  |
| a\. Application for benefits e.  | Third party disclosure            |
| Program planning or management   |                                   |
|                                  | c\. \[ x \] Reporting             |
| b\. Program evaluation f.        |                                   |
| Research                         | 1\. \[x \] On occasion 2. \[ \]   |
|                                  | Weekly 3. \[ \] Monthly           |
| c\. General purpose statistics   |                                   |
| g.X Regulatory or compliance     | 4\. \[ \] Quarterly 5. \[ \]      |
|                                  | Semi-annually 6. \[ \] Annually   |
| d\. Audit                        |                                   |
|                                  | 7\. \[ \] Biennially 8. \[ \]     |
|                                  | Other (describe)                  |
+----------------------------------+-----------------------------------+
| 17\. Statistical methods         | 18\. Agency Contact (person who   |
|                                  | can best answer questions         |
| Does this information collection | regarding                         |
| employ statistical methods \[ \] |                                   |
| Yes \[x \] No                    | the content of this submission)   |
|                                  |                                   |
|                                  | Name: [Howard Muller / Karen      |
|                                  | Nelson]{.underline}               |
|                                  |                                   |
|                                  | Phone: [301-594-5601              |
|                                  | 301-827-1482]{.underline}         |
+----------------------------------+-----------------------------------+

OMB 83-I 10/95

+---------------------------------------------------------+------------+
| **19. Certification for Paperwork Reduction Act         |            |
| Submissions**                                           |            |
|                                                         |            |
| On behalf of this Federal Agency, I certify that the    |            |
| collection of information encompassed by this request   |            |
| complies with                                           |            |
|                                                         |            |
| 5 CFR 1320.9                                            |            |
|                                                         |            |
| **NOTE:** The text of 5 CFR 1320.9, and the related     |            |
| provisions of 5 CFR 1320.8(b)(3), appear at the end of  |            |
| the                                                     |            |
|                                                         |            |
| instructions. *The certification is to be made with     |            |
| reference to those regulatory provisions as set forth   |            |
| in*                                                     |            |
|                                                         |            |
| *the instructions.*                                     |            |
|                                                         |            |
| The following is a summary of the topics, regarding the |            |
| proposed collection of information, that the            |            |
| certification covers:                                   |            |
|                                                         |            |
| \(a\) It is necessary for the proper performance of     |            |
| agency functions;                                       |            |
|                                                         |            |
| \(b\) It avoids unnecessary duplication;                |            |
|                                                         |            |
| \(c\) It reduces burden on small entities;              |            |
|                                                         |            |
| \(d\) It used plain, coherent, and unambiguous          |            |
| terminology that is understandable to respondents;      |            |
|                                                         |            |
| \(e\) Its implementation will be consistent and         |            |
| compatible with current reporting and recordkeeping     |            |
| practices;                                              |            |
|                                                         |            |
| \(f\) It indicates the retention period for             |            |
| recordkeeping requirements;                             |            |
|                                                         |            |
| \(g\) It informs respondents of the information called  |            |
| for under 5 CFR 1320.8(b)(3):                           |            |
|                                                         |            |
| \(i\) Why the information is being collected;           |            |
|                                                         |            |
| \(ii\) Use of information;                              |            |
|                                                         |            |
| \(iii\) Burden estimate;                                |            |
|                                                         |            |
| \(iv\) Nature of response (voluntary, required for a    |            |
| benefit, mandatory);                                    |            |
|                                                         |            |
| \(v\) Nature and extent of confidentiality; and         |            |
|                                                         |            |
| \(vi\) Need to display currently valid OMB control      |            |
| number;                                                 |            |
|                                                         |            |
| \(h\) It was developed by an office that has planned    |            |
| and allocated resources for the efficient and effective |            |
| manage-                                                 |            |
|                                                         |            |
| ment and use of the information to be collected (see    |            |
| note in Item 19 of instructions);                       |            |
|                                                         |            |
| \(i\) It uses effective and efficient statistical       |            |
| survey methodology; and                                 |            |
|                                                         |            |
| \(j\) It makes appropriate use of information           |            |
| technology.                                             |            |
|                                                         |            |
| If you are unable to certify compliance with any of the |            |
| provisions, identify the item below and explain the     |            |
| reason in                                               |            |
|                                                         |            |
| Item 18 of the Supporting Statement.                    |            |
+---------------------------------------------------------+------------+
| Signature of Senior Official or designee                | Date       |
+---------------------------------------------------------+------------+

OMB 83-I 10/95

**pranepa.ss.wpd 5/20/03**