SUPPORTING STATEMENT FOR

INFORMATION COLLECTION REQUEST NUMBER 0938.16 (2030-0020)

“GENERAL ADMINISTRATIVE REQUIREMENTS FOR ASSISTANCE PROGRAMS”

1.	Identification of the Information Collection

This is a request for a renewal of an existing Information Collection
Request (ICR) due to expire on April 30, 2009.  This ICR authorizes the
collection of information under EPA’s General Regulation for
Assistance Programs that establishes the minimum management requirements
for all recipients of EPA grants or cooperative agreements (assistance
agreements).  40 CFR Part 30, “Grants and Agreements with Institutions
of Higher Education, Hospitals, and Other Non-Profit Organizations,”
establishes the management requirements for institutions of higher
education, hospitals, and other non-profit organizations, as well as
procurement requirements for non-governmental recipients.  40 CFR Part
31, “Uniform Administrative Requirements for Grants and Cooperative
Agreements to State and Local Governments,” includes the management
requirements for States, local governments, and Indian Tribal
governments.  These regulations include only those provisions mandated
by statute, required by Office of Management and Budget (OMB) Circulars,
or added by EPA to ensure sound and effective financial assistance
management.

In addition, under Executive Orders 11625, 12138, and 12432, EPA is
required to promote and report on programs to assist minority and
women-owned enterprises.  Under P.L. 101-507 and P.L. 102-389, EPA is
required to set aside funds for socially and disadvantaged
individuals/firms under the Small Business Act, 15 U.S.C. 537(a) (5) and
(6).  This ICR combines all of these requirements under OMB Control
Number 2030-0020.  EPA award officials will use the information required
by these regulations to make assistance awards, to make assistance
payments, and to verify that the recipient is using Federal funds
appropriately to comply with Federal requirements.

This request renews the “General Administrative Requirements for
Assistance Programs” ICR by consolidating and updating the information
contained in the following ICRs previously approved by OMB:

“General Administrative Requirements for Assistance Programs” ICR
Number 0938.11 (base ICR) - requested approval for collection of
information under EPA’s assistance programs.

“General Administrative Requirements for Assistance Programs” ICR
Number 0938.12 (amendment ICR) - requested approval of EPA Form 6600-01,
“EPA Administrative and Financial Onsite Review Questionnaire.”

“General Administrative Requirements for Assistance Programs” ICR
Number 0938.13 (amendment ICR) - eliminated EPA Form 5700-53 and
adjusted the burden hours under the ICR accordingly.

“General Administrative Requirements for Assistance Programs” ICR
Number 0938.14 (amendment ICR) - requested approval of nonsubstantive
modifications to existing EPA Form 4700-4, “Preaward Compliance Review
Report for All Applicants and Recipients Requesting Federal Financial
Assistance.”

“General Administrative Requirements for Assistance Programs” ICR
Number 0938.15 (amendment ICR) - requested approval of nonsubstantive
modifications to existing EPA Form 4700-4, “Preaward Compliance Review
Report for All Applicants and Recipients Requesting Federal Financial
Assistance.”

In approving the “General Administrative Requirements for Assistance
Programs” ICR Number 0938.11, OMB issued terms of clearance.  Each
term is enumerated below in bold, followed by EPA’s response
explaining how it was addressed.

1) “EPA Administrative Capability Questionnaire” Form.  While EPA
may retain question 2a and ask applicants to identify affiliated
organizations, EPA should seriously explore performing validations of
the information via reports from Dunn and Bradstreet on all affiliations
of the applicant.  This validation could be a one-time check on new
applicants, and repeated when/if EPA wishes to recheck.

EPA response:  EPA thanks OMB for the suggestion to validate
applicants’ affiliations using Dunn and Bradstreet reports.  EPA has
carefully evaluated this option and found that obtaining Dunn and
Bradstreet data and performing the validations would be too expensive
given the resources available to the Agency.  In addition, EPA notes
that Dunn and Bradstreet may issue different numbers to the affiliates
and subsidiaries of an organization.  Because of this, it can be
difficult to determine affiliations among grant applicants based on Dunn
and Bradstreet data.  Therefore, EPA has retained its current practice
of asking applicants to complete question 2a on each questionnaire
submitted.

2) EPA Form 5700-53 “Lobbying and Litigation Certification for Grants
and Cooperative Agreements” is approved only until this data
collection is no longer required under statute or applicable
appropriations requirements.  If EPA determines that this data
collection is no longer required by applicants, the Agency should submit
a change worksheet (Form 83-C) consistent with OMB guidelines.

EPA response: EPA Form 5700-53 has been eliminated.  EPA submitted
“General Administrative Requirements for Assistance Programs” ICR
0938.13 to eliminate the form and to adjust the burden under the ICR
accordingly.

3) EPA “Lobbying Cost Certificate for Indirect Costs” Form.  This
new data collection has been approved for use by EPA until the standard,
government-wide data collection is completed.  EPA should integrate its
current indirect cost rate efforts with the interagency team currently
working on standard indirect cost rate guidance that will be used
government-wide, in order to ensure that EPA’s needs are considered in
the government-wide guidance.

EPA response:  EPA thanks OMB for its suggestion to integrate our
current indirect cost rate efforts with the interagency team’s
activities.  EPA notes, however, that no substantial movement toward
establishing a standard, government-wide data collection has been made.
Therefore, EPA will continue to use the EPA form.

4) NCER Form 3212, “Itemized Budget for EPA STAR Grant
Applications.”  This data collection has been approved for use by EPA
until the SF-424A “Budget Information” has been updated and
incorporated into the Grants.gov forms library for grant application use
government-wide.  EPA is advised to participate in the Grants.gov
Standard Forms team to ensure EPA’s needs are considered in the
SF-424A update.

EPA response: NCER Form 3212 has been eliminated.  EPA has reflected
elimination of the form in this ICR.

2.	Need For/Use of the Collection

2(a) Need.  This ICR is necessary because of the information collection
and reporting requirements included in EPA regulations at 40 CFR Parts
30 and 31.  These regulations implement OMB Circulars A-21, A-87, A-102,
A-110, A-122, A-128, and A-133.  These regulations set forth the
pre-award, post-award, and after-the-grant requirements.  This
information is needed by EPA project officers, grant specialists, and
finance officials to manage/oversee recipient programmatic and financial
performance under all EPA assistance agreements.

2(b) Use.  The pre-award information is used to qualify and select
grant/cooperative agreement applicants for funding.  The post-award
information is used to meet the statutory and regulatory requirements
and monitor recipient performance.  The after-the-grant information is
used to meet reporting and recordkeeping requirements and to close out
awards.  The information is necessary to ensure minimum fiscal control
and accountability for EPA funds and to deter waste, fraud, and abuse.

3.	Description of EPA Grant Forms

The following identifies the application forms and non-form reporting
requirements contained in this regulation.  Clearance for some of these
requirements has been requested or approved under a separate clearance
package.  A detailed justification for each reporting requirement
immediately follows.  Burden estimates are summarized in Exhibit A.

(1)	EPA Form 6600-09, “EPA Administrative Capability Questionnaire,”
is completed by non-profit organizations seeking EPA grant awards of
more than $200,000.  Based on the information provided, EPA assesses the
adequacy of an applicant’s administrative and financial management
systems (i.e., administrative capability) and determines whether to
award the grant.  Applicants that provide information that demonstrates
that they are administratively and financially capable are
“certified” for the next four years.  The questionnaire is necessary
because it assists organizations identify potential system weaknesses
and compliance problems and correct them before grant award.  This helps
applicants avoid potential EPA corrective actions (e.g., freezing grant
funds), which could place their project in jeopardy.

In 2004, we conducted 267 post-award administrative reviews of
recipients, which resulted in 127 or 48% reviews with findings.  In
response to concerns about EPA’s oversight of non-profit recipients
raised in Congressional Hearings and by the Government Accountability
Office, as well as EPA’s Office of Inspector General, EPA prepared the
Administrative Capability Questionnaire to be used in the pre-award
review process.

In January 2005, EPA conducted two pilot tests of the questionnaire.
The tests were designed to evaluate whether the questionnaire would
provide information to enable the Agency to effectively evaluate the
ability of prospective applicants to comply with applicable EPA and OMB
requirements.  Based on the completed questionnaires, EPA identified a
total of eight weaknesses in the two organizations in the pilot tests.
These weaknesses included deficiencies in administrative/accounting
procedures (e.g., withdrawal/payment of funds, determination of
allowable costs), property/procurement procedures (e.g., lack of an
established written policy for procurements), and personnel/travel
procedures (e.g., missing code of conduct and fringe benefit policy).
From the pilot tests, EPA has concluded that the questionnaire provides
information that is needed by the Agency to evaluate prospective
applicants so that weaknesses/deficiencies are corrected before grants
are awarded.

Because of the success of the pilots, EPA has continued to use the
questionnaire.  EPA has used the form to evaluate more than 250
organizations, resulting in more than 300 weaknesses/deficiencies
identified.

We estimate that the form will impose 4 burden hours on the applicant
and 3 burden hours on EPA.  Further, we would like to continue to apply
the pre-award review process under certain special conditions (e.g.,
high-risk recipients and to other applicants below these thresholds in
special circumstances).  We estimate that this could result in
additional recipient burden hours of approximately 80.

(2)	EPA Form 4700-4, “Preaward Compliance Review Report for All
Applicants and Recipients Requesting Federal Financial Assistance,” is
used to collect information that enables EPA to determine whether
applicants are developing projects, programs, and activities on a
non-discriminatory basis.  We estimate that this form will impose 0.5
burden hour on the applicant and 0 burden hours on EPA.

(3)	EPA Form 5700-54, “Key Contacts Form,” and EPA Form 5700-55,
“Key Contacts Form for Multiple Principal Investigators.”  These
forms are used to collect contact information for individuals
responsible for various aspects of the proposed work, including
authorized representative, payee, administrative contact, and
investigators.  A recipient must complete either form as applicable.  We
estimate that a form imposes 0.5 burden hour on the applicant and 0
burden hours on EPA.

(4)	EPA Form 5770-2, “Fellowship Application,” is the basic
application form and requires information on the applicant’s
educational and work experience background.  We estimate that this form
imposes 3 burden hours on the applicant and 3 burden hours on EPA.

(5)	EPA Form 5770-3, “Fellowship Facilities and Commitment
Statement,” requires information about the institution that will
sponsor the applicant, the sponsor’s summarized plans for the
applicant’s training, and the institution’s commitment to provide
that training.  We estimate that this form imposes 1 burden hour on the
applicant and 1 burden hour on EPA.

(6)	EPA Form 5770-4, “Fellowship Applicant Qualifications Inquiry,”
asks for comments on the applicant’s qualifications for a fellowship
in the pollution control and abatement area.  The form also asks the
respondent to provide an overall evaluation of the applicant.  We
estimate that this form imposes 3 burden hours on the applicant and 0.25
burden hour on EPA.

(7)	EPA Form 5770-5, “Agency Fellowship Certification,” is used by
applicants who are current or prospective employees of a regional,
State, or local environmental pollution control or regulatory agency.
The form asks the agency director or designee for the kind of help
(financial, leave of absence, etc.) the agency will be providing the
applicant if he receives an EPA fellowship.  We estimate that this form
imposes 0.5 burden hour on the applicant and 0.5 burden hour on EPA.

(8)	EPA Form 5770-7, “EPA Fellowship Activation Notice,” is used by
EPA to inform EPA’s Regional Services Staff to begin payment on the
fellowship award.  We estimate that this form imposes 0.5 burden hour on
the recipient and 0.5 burden hour on EPA.

(9)	EPA Form 5770-8, “Fellowship Agreement,” contains the terms of
the fellowship agreement, and is used by the applicant to formally
accept an EPA fellowship.  We estimate that this form imposes 1 burden
hour on the recipient and 1 burden hour on EPA.

(10)	EPA Form 5770-9, “EPA Fellowship Termination Notice,” is used
to officially terminate the fellowship.  The form requires the recipient
to provide EPA with two reprints of any publication work done under the
fellowship, when available, and asks for constructive criticism from the
recipient or his sponsor on EPA’s fellowship program.  We estimate
that this form imposes 1 burden hour on the recipient and 1 burden hour
on EPA.

(11)	EPA Form 6600-01, “EPA Administrative and Financial Onsite Review
Questionnaire,” is used to collect financial information from
recipients.  EPA uses the information to determine if recipients are in
compliance with government-wide and EPA-specific rules, regulations and
guidelines promulgated in the various OMB Circulars, Code of Federal
Regulations, and Agency directives.  Additionally, it is reviewed to
determine if recipients have good business practices, such as
consistently applied policies and procedures that safeguard the
management and use of Federal funds.  The form provides the Agency with
information needed to conduct and complete its statistical analyses and
evaluation of recipients.  The information is collected on a
statistically determined and random basis spread over the various types
of organizations receiving funds from EPA.  We estimate that the form
imposes 30 burden hours on the recipient and 40 burden hours on EPA.

(12) 	EPA Form 6600-06, “Certification Regarding Lobbying,” is
completed by grant recipients and contains certifications about the use
of Federal appropriated funds in connection with lobbying, as specified.
 The form is used by EPA to confirm that no funds have been used for
lobbying activities and, if applicable, to direct the recipient to
complete Standard Form-LLL, Disclosure Form to Report Lobbying.”  We
estimate that this form imposes 0.25 burden hour on the recipient and
0.03 burden hour on EPA.

(13)	EPA Form 6600-08, “Lobbying Cost Certificate for Indirect
Costs,” is completed by grant recipients and contains the
certification required by OMB Circular A-122.  The form is used by EPA
to ensure compliance with the requirements and standards on lobbying
costs in OMB Circular A-122.  We estimate that this form will impose
0.25 burden hour on the recipient and 0.17 burden hour on EPA.

(14)	NCER Form 5, “Current and Pending Support,” is used by EPA to
determine whether the principal investigator has available capability to
handle the additional workload proposed by EPA under the grant.  We
estimate that this form will impose 0.5 burden hour on the applicant and
0.25 burden hour on EPA.

(15)	SF-269, “Financial Status Report” - Family of Forms.  This form
is for recipients to report the status of funds for non-construction
projects or programs.  OMB requires that recipients submit a SF-269 at
the completion of each project.  We estimate that this form imposes 0.5
burden hour on the recipient and 2 burden hours on EPA.

(16)	SF-270, “Request for Advance or Reimbursement.”  This is the
standard form prescribed by OMB Circular A-102 for recipients to use to
request advances or reimbursement on all non-construction programs when
the advance payment or reimbursement methods are used.  We estimate that
this form will impose 1 burden hour on the recipient and 1.5 burden
hours on EPA.

(17)	SF-271, “Outlay Report and Request for Reimbursement for
Construction Programs.” This is the standard form prescribed by OMB
Circular A-102 for recipients of a construction grant to request
reimbursements.  We estimate that this form imposes 1 burden hour on
recipients and 0.5 burden hour on EPA.

(18)	SF-272, “Federal Cash Transactions Report”- Family of Forms.
This is the standard form prescribed by OMB Circular A-102 for
recipients to report cash transactions when the Automated Clearinghouse
payment method is used.  We estimate that this form imposes 2 burden
hours on the recipient and 2 burden hours on EPA.

(19)	SF-424, “Application for Federal Assistance,” is used by
States, local governments, and Federally recognized Indian Tribal
governments to apply for Federal financial assistance.  SF-424 requires
basic information about the applicant (name, address, telephone number,
type of applicant, etc.), including a list of sources of proposed
funding and a description of the proposed project.  Supplemental
information is provided in SF-424A, “Budget Information -
Non-Construction Programs,” SF-424B, “Assurances - Non-Construction
Programs,” SF-424C, “Budget Information - Construction Programs,”
and/or SF-424D, “Assurances - Construction Programs,” as applicable.

We estimate that, collectively, these forms will impose 4 burden hours
on the recipient and 5 burden hours on EPA.

(20)	The SF-LLL, “Disclosure of Lobbying Activities,” is used by
applicants to disclose lobbying activities that have been secured to
influence the outcome of a Federal action (e.g., contract, grant,
cooperative agreement, etc.).  We estimate that this form will impose
0.17 burden hour on the recipient and 0 burden hours on EPA.

4.	Reporting and Recordkeeping Requirements

(1)	SECTIONS 30.22 and 31.21 require recipients to establish a separate
bank account if the recipient uses the Automated Clearing House (ACH)
method of payment (Treasury Circular 1075, as revised).  EPA uses the
ACH method to pay 401 recipients.  We estimate the ACH payment method
imposes 2 burden hours on the recipient and 1 burden hour on EPA.

(2)	SECTIONS 30.50 & 52 and 31.42 require recipients to establish an
official record file for each assistance award to track how the
recipient uses the project funds, to account for property purchased
under the award or used as part of any in-kind contributions, to
maintain time records, and to document compliance with applicable
statutes and regulations.  We estimate that this requirement imposes 5
burden hours on the recipient and 1 burden hour on EPA.

The EPA Office of Grants and Debarment has developed various instruments
to assist the Agency in information collection and reporting
requirements needed by EPA project officers, grant specialists, and
finance officials to manage and oversee recipient’s programmatic and
financial performance under all EPA assistance agreements.  One set of
these management instruments is used to assist EPA in evaluating the
financial, technical, and administrative management systems of
recipients through desk reviews and/or on-site visits.  These
evaluations focus on a recipient institutions’ financial, personnel,
property, and procurement records, systems, and procedures.  Information
is gathered and evaluated to ensure that recipients are complying with
applicable State and Federal laws concerning employment, procurement,
and recordkeeping procedures.  The information is also used to confirm
that recipients are staffing their institutions with personnel qualified
to perform the tasks necessary to implement the agreement.  We estimate
that less than 15% of the recipients will complete these reviews.  For
those who do complete these reviews, we estimate 2 burden hours on the
recipient and 2 burden hours on EPA.

EPA project officers may use another evaluation instrument to perform
reviews that pertain to programmatic components of assistance
agreements.  This second type of evaluation focuses on reviewing
information that can help assess recipients’ activities and progress
toward meeting the goals and objectives outlined in the assistance
agreements.  Programmatic reviews also ensure that the work to be
performed under the agreement is on schedule, within budget, and
consistent with the agreements’ relevant programmatic regulation
and/or programmatic terms and conditions.  We estimate that about 8% of
the recipients will complete these reviews.  For those who do complete
these reviews, we estimate 1 burden hour on the recipient and 1 burden
hour on EPA.

The extent of the information gathered and reviewed through these two
types of instruments will vary according to the size and scope of each
agreement.  Complex agreements that involve large financial grants and
entail extensive staffing and complex tasks will require a greater
degree of review and evaluation.  Regardless of the size or complexity
of the assistance agreement, these review instruments create a framework
that allows EPA to ensure the sound and effective management of
assistance agreements.

(3)	SECTIONS 30.54 and 31.45 require recipients to develop and implement
quality assurance practices that meet project objectives and minimize
loss of data due to out-of control conditions or malfunctions.  This
requirement was cleared under a separate submission (OMB Control No.
2000-0403).

(4)	SECTIONS 30.51 and 31.40 require recipients to submit interim and
final progress reports, if required.  EPA uses the interim progress
reports to determine progress in relation to the approved schedule and
project milestones during the project.  The final progress report
summarizes all of the work on the project and the extent to which the
recipient has met the project’s objectives.  We estimate that this
requirement imposes a total of 6.5 burden hours on the recipient and 4
burden hours on EPA.

(5)	SECTION 30.36 requires recipients to submit invention reports after
completion of each project.  This requirement will be cleared under a
separate ICR.  (Part 31 does not address inventions.)

(6)	SECTIONS 30.33 and 31.32 require recipients to submit an inventory
report on all Federally-owned property used on a project.  We estimate
that 5% of EPA funded projects use Federally-owned property, and that
this requirement imposes 4 burden hours on those recipients and 1 burden
hour on EPA.

(7)	SECTIONS 30.21 and 31.20 require the recipient to maintain a
financial management system that consistently applies accepted
accounting principles and practices.  To be eligible for an assistance
award, the recipient must have an adequate financial management system
that provides efficient and effective accountability and control of all
property, funds, and assets.  Therefore, the burden this requirement
imposes is the additional time a recipient must spend to maintain the
system for an EPA award.  We estimate this to be 2 burden hours on
recipients and 1 burden hour on EPA.

OMB Circular A-133 requires that State and local government recipients
perform an audit of their Federal assistance agreements every year
unless there is a statutory provision allowing an audit every two years.
 The audit is required to determine compliance with generally accepted
accounting practices and with EPA program requirements.  We estimate
that this audit will impose 2 burden hours on the recipient and 0 burden
hours on EPA.

The reporting and record requirements burden estimates of Sections 30.25
through 31.36(h) (below) are not listed in Exhibit A due to low
frequency of applicability and /or minimal response burden to applicants
and recipients of EPA grants.

(8)	SECTIONS 30.25 and 31.32 require recipients to obtain the award
officials approval before purchasing property or equipment with a unit
acquisition cost of $5,000 or more.

We estimate that this requirement applies to about 20% of the
non-construction assistance recipients, and that this requirement
imposes 3 burden hours on those recipients and 2 burden hours on EPA.

(9)	SECTIONS 30.30 - 37 and 31.32 require recipients to comply with
specific property management standards.  The recipient is required to
keep accurate records and carry out a physical inventory of property and
reconcile the results, at least every two years.  We estimate that this
requirement imposes 3 burden hours on the recipient and 2 burden hours
on EPA.

(10)	SECTIONS 30.34, 35 & 36 and 31.32, 33 & 34 contain requirements on
how recipients are to dispose of Federally-funded personal property.  We
estimate that about 2% of the projects on which the recipient purchases
property involve personal property disposal actions, and that this
requirement imposes 3 burden hours on recipients and 2 burden hours on
EPA.

(11)	SECTIONS 30.32 and 31.31 contain requirements on how recipients
purchase and dispose of real property.  We estimate that this
requirement imposes 4 burden hours on recipients and 2 burden hours on
EPA.

(12)	SECTIONS 30.33 and 31.32 contain the requirements on how recipients
are to manage Federally-owned property.  We estimate that this
requirement affects only 1% of the projects, and imposes 2 burden hours
on those recipients and 2 burden hours on EPA.

(13)	SECTIONS 30.4 and 31.6 contain the requirements recipients must
follow to request a deviation from an EPA regulation.  Only 5% of all
recipients request deviations.  We estimate that a deviation imposes 8
burden hours on the recipient and 8 burden hours on EPA.

(14)	SECTIONS 30.63 and 40 CFR 31 Subpart F contain the procedures the
recipient must follow to appeal an assistance agreement dispute between
the recipient and the award official.  We estimate that this requirement
imposes 16 burden hours on the recipient and 16 burden hours on EPA.
Less than 1% of EPA grant awards result in disputes.

(15)	SECTIONS 30.40 - 48 and 31.36 contain the procurement requirements
recipients must follow. We estimate that this requirement imposes 0.5
burden hour on the recipient and 0.5 burden hour on EPA.

(16)	SECTION 31.11 requires recipients to follow 40 CFR Part 29, which
implements Executive Order 12372, “Intergovernmental Review of Federal
Programs,” revokes OMB Circular A-95, and establishes new procedures
for intergovernmental reviews.  OMB has determined that the new
requirements are not subject to the reporting burden clearance process.

(17)	SECTION 31.36(h) contains the bonding and reporting requirements
recipients must follow.  We estimate that this requirement imposes 0.5
burden hour on the recipient and 1 burden hour on EPA.

5.	Respondents and Information Requested

5(a).  The primary recipients of EPA grants are State and local
governments, Indian Tribes, educational institutions, and not-for-profit
institutions.  The information requested is used to make awards, pay
recipients, and collect information on how Federal funds are being
spent.

5(b).  Grants.gov, originally called the E-Grants Initiative, was a
mandate of the President’s Fiscal Year 2002 Management Agenda, which
directed agencies to “…allow applicants for Federal Grants to apply
for and ultimately manage grant funds online through a common Web site,
simplifying grants management and eliminating redundancies.”

Grants.gov implements the requirement in the Federal Financial
Assistance Management Improvement Act, Public Law 106-107, to develop a
simple, unified source to electronically find, apply, and manage grant
opportunities.  Grants.gov is the central Federal electronic portal
envisioned by the Act.  EPA’s support and adoption of Grants.gov will
be a major factor in maintaining the Agency’s “green” rating under
the President’s Balanced Scorecard.

Grants.gov Apply allows an applicant to download a proposal/application
package from Grants.gov and complete the package offline based on agency
instructions.  The proposal/application package of forms generally
includes a standard set of core data elements based on the updated
version of the SF-424.  After an applicant completes the required
proposal/application package of forms, they can be submitted
electronically to Grants.gov, which transmits the proposal/application
to the funding agency.

The Office of Grants and Debarment has constructed a Grants.gov
Application Database (EAPPLY) that receives the proposal/application
data and stores them for program retrieval or review.  As
proposals/applications are selected for funding, the data will migrate
to the associated Integrated Grants Management System database for
eventual award.

EPA encourages use of Grants.gov for all competitive grants.

Standard Industrial Classification Codes for respondents include 8211,
8221, 8399, and 919.  The corresponding North American Industry
Classification System (NAICS) Codes for respondents include 61111,
61131, 813212, 813219, 813311, 813312, 813319 and 92119.

5(c).  See the attached forms for specific data elements (Exhibit B
lists the forms).

6.	The Information Collected—Agency Activities, Collection
Methodology, and Information Management

6(a).  These data collection forms are reviewed periodically to identify
and eliminate duplication in reporting requirements.  Similar
information is simply not available elsewhere.

6(b).  Most of the information will be collected using standardized
reports and appropriate recordkeeping.  This information is entered into
IGMS, the Integrated Grants Management System, the Agency’s database
for tracking the status of grant/cooperative actions.

6(c).  These reports are reviewed in accordance with the requirements of
40 CFR Parts 30 and 31.  The Agency also conducts periodic on-site
reviews to ensure recipient compliance with applicable requirements.
Recipients are required to retain all records for three years following
submission of the final Financial Status Report.

7.	Nonduplication, Consultations, and other Collection Criteria

7(a).  There is no other source for this information.

7(b).  Administering EPA grants requires constant recipient contact
(e.g. written, telephone, face to face, etc.).  The EPA Office of Grants
and Debarment (OGD) is both sensitive and responsive to recipient
concerns involving burden, duplication, availability of data, clarity of
instructions, etc.  OGD is continually revising EPA grant forms and
collection methods in an effort to address recipient concerns and
streamline their activities.  For example, in 2007, as part of an effort
to reduce the administrative burden to respondents under the program,
OGD evaluated the possibility of allowing State grant applicants to make
one “bundled” submittal of specified grant forms annually (e.g., SF
424B, EPA Form 4700-4) rather than having to submit them with each
application for assistance.  EPA found this bundling to be a reasonable
accommodation for State applicants.  It is therefore EPA’s policy to
permit EPA’s regional Grants Management Offices to collect these
bundled submittals from States in order to ease their burden.  EPA
estimates that this policy results in a potential burden savings to
recipients of about 1,000 hours per year.  (These savings are not
reflected in the burden calculations of this ICR.)

Frequent applicant and recipient feedback and informal consultations
have been a significant part of EPA grant forms evaluation.  These
contacts have been particularly useful in developing burden estimates.
However, the bulk of recipient burden involves completing Federal
Standard Forms (e.g., SF 424).  All of the basic information
requirements under these regulations have already been subject to
considerable comment by recipients through OMB’s revisions to Circular
A-102.

This ICR is requesting clearance for a number of EPA grant forms.  They
are used by respondents on a regular basis and made publicly available
in several different locations (e.g., various web sites) in both
electronic and hardcopy format.  Because of these factors, it is
difficult for EPA to update the expiration date of OMB approval on all
of them on a continual basis.  EPA is therefore requesting that it be
relieved of the requirement to include an expiration date on the forms
in this ICR.

7(c).  No less frequent collection is possible in accordance with OMB
requirements.

7(d).  The information collection is consistent with 5 CFR 1320.5(d)(2).

7(e).  In 1996, the regulations of Part 30 were revised to reflect
“plain English.”  EPA has continued to use plain English since then.
 As a result, EPA’s grant regulations and other documents are easier
to understand by all organizations, large and small.

No pledge of confidentiality is given for applicant responses and no
sensitive information is collected under this ICR.

7(g).  Consultations - we have received continuous feedback from
recipients on this information collection.

8.	Estimating the Burden and Cost of the Collection

8(a).  An estimation of the burden hours per requirement is included in
Exhibit A.

Type of Information	Number of Respondents

Completed Grants	Unsuccessful Applications	1,474

	Awards	1,744

Not Competed Grant Awards	1,898

Fellowship Awards	989

TOTAL	6,105

8(b).  RECIPIENTS: The total annual burden hours for recipients is
estimated to be 114,531.  114,531 hours divided by 6,105 respondents =
19 hours per respondent.

EPA estimates that 80% of these 19 hours will be used by the applicant
(15 hours) and the remaining 20% by secretarial/clerical staff (4
hours).

Therefore:	Applicant Wage Rate:  $40.88 x 1.43 = $58.46.

Secretarial/Clerical Wage Rate:  $16.51 x 1.43 = $23.61.

Thus: 	6,105 respondents x 15 hours x $58.46 = $5,353,475 and

6,105 respondents x 4 hours x $23.61 = $576,556.

Total: 	$5,930,031 (labor costs).

8 (c)  FEDERAL:  The total annual burden hours for EPA is estimated to
be 87,265.  87,265 hours divided by 6,105 respondents = 14 hours per
respondent for EPA.

            Thus:     6,105 respondents x 14 hours x $40.91  =
$3,496,578 (labor costs).

	8(d).  Bottom Line Burden Estimate.

          	Total burden hours for respondents = 114,531 hours.

          	Total burden hours for EPA = 87,265 hours.

Reasons for change in burden

The overall respondent burden has increased from the previous ICR by
5,917 hours (i.e., from 108,614 hours to 114,531 hours).  As shown in
the table below, this change has occurred for several reasons.

EPA carefully reviewed the set of grant and fellowship forms covered in
this ICR.  Based on this review, and in accordance with the OMB terms of
clearance, the Agency eliminated NCER Form 3212, “Itemized Budget for
EPA STAR Grant Applications.”  In addition, EPA added the form,
“Certification Regarding Lobbying.”  This form is necessary for EPA
to confirm that no funds have been used for lobbying activities and, if
applicable, to direct the recipient to complete Standard Form-LLL,
“Disclosure Form to Report Lobbying.”  These program changes
resulted collectively in a decrease of 346 hours.

In addition, EPA reviewed the burden assumptions (e.g., estimated number
of respondents) in the ICR to ensure that they reflect the Agency’s
current experiences under its grant programs.  Based on this review, EPA
made an adjustment in the burden hours for completion of EPA Form,
“EPA Administrative and Financial Onsite Review Questionnaire.”  EPA
estimates that 200 recipients will spend 30 hours to complete the form
annually.  In addition, EPA increased the number of respondents who will
complete EPA Form, “Lobbying Cost Certificate for Indirect Costs.”
EPA increased the number of respondents from 1,450 to 2,500.  These
adjustments resulted in an increase of 6,263 hours.

The net effect of these program changes and adjustments is an increase
of 5,917 hours from the previous ICR.

Type of Change	Hours

Program Changes

Deleted Forms

NCER Form 3212, “Itemized Budget for EPA STAR Grant Applications”
-1,300

Added Forms

"Certification Regarding Lobbying"	954

Subtotal: Program Changes	-346

Adjustments

“EPA Administrative and Financial Onsite Review Questionnaire”	6,000

"Lobbying Cost Certificate for Indirect Costs"	263

Subtotal: Adjustments	6,263

Net Change in Hours	5,917

8(e).  Without the data compiled by the use of the forms, it would be
impossible for EPA to manage any of its Federal assistance programs.
Rational, fair grant awards would be extremely difficult to make, and
financial and technical managerial information would not be available to
judge the status of grant efforts.  Lessening the frequency of data
collection would have similar negative impacts.

9.   	Start-up/Capital Costs and Operation and Maintenance Costs

Start-up costs for EPA grant applications and associated forms are
minimal and are part of customary and usual recipient business expenses.
 There are no capital costs related to EPA grant applications and
related reporting requirements.  Therefore, total start-up and capital
costs are zero (0). There are no O&M costs required.

10.  	Special Circumstances for Change

Not applicable.  There are currently no special circumstances that would
cause EPA grants information collection efforts to change.

11.  	Federal Register Announcement

A notice was published on page 65307 of the November 3, 2008, Federal
Register, announcing that EPA was beginning to prepare this ICR.  No
comments were received in response to the notice.

12.  	Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 19 hours per respondent.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.

To comment on the Agency’s need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-OARM-2005-0001, which is available for public viewing at the
Office of Environmental Information Docket in the EPA Docket Center
(EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington,
DC.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays.  The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Office of Environmental Information Docket is
(202) 566-1752.  An electronic version of the public docket is available
online at www.regulations.gov.  Use www.regulations.gov to submit or
view public comments, access the index listing of the contents of the
public docket, and to access those documents in the public docket that
are available electronically.  Once in the system, select “search,”
then key in the docket ID number identified above.  Also, you can send
comments to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, DC 20503,
Attention:  Desk Office for EPA.  Please include the Docket ID No.
EPA-HQ-OARM-2005-0001.EXHIBIT A

ANNUAL ESTIMATE OF EPA ASSISTANCE AGREEMENT AWARDS

Type of Information	Number of Respondents

Completed Grants	Unsuccessful Applications	1,474

	Awards	1,744

Not Competed Grant Awards	1,898

Fellowship Awards	989

TOTAL	6,105

The above estimates were used to determine the number of actions per
year for each of the following reporting requirements.

BURDEN HOURS PER REPORTING REQUIREMENT

NOTES:	Column D = A x B x C

Column F = A x B x E

Burden estimates for analyzing, processing, and maintaining EPA grant
forms were derived from EPA employees directly responsible for
day-to-day grant operations.  Employee estimates were obtained shortly
after forms were approved for use and have been modified to reflect our
grant processing streamlining efforts.

Reporting and recordkeeping requirement burden estimates for Sections
30.25 through 33.211 of 40 CFR are not listed in Exhibit A due to the
low frequency or applicability and/or minimal response burden to
applicants and recipients of EPA grants.

Information Collection Requirement	A	B	C	D	E	F

	Actions per Year	Submissions per Agreement	Burden Hours per Action
Total Burden Hours for Recipients	Burden Hours for EPA	Total Burden
Hours for EPA

EPA Form 6600-09, "EPA Administrative Capability Questionnaire"	200	1	4
800	3	600

EPA Form 4700-4, “Preaward Compliance Review Report for All Applicants
and Recipients Requesting Federal Financial Assistance”	3,417	1	0.5
1,709	0	0

EPA Form 5700-54, “Key Contacts Form” and EPA Form 5700-55, “Key
Contacts Form for Multiple Principal Investigators”	3,417	1	0.5	1,709
0	0

EPA Form 5770-2, “Fellowship Application” 	989	1	3	2,967	3	2,967

EPA Form 5770-3, “Fellowship Facilities and Commitment Statement”
989	1	1	989	1	989

 EPA Form 5770-4, “Fellowship Applicant Qualifications Inquiry” 	989
1	3	2,967	0.25	247

EPA Form 5770-5, “Agency Fellowship Certification” 	989	1	0.5	495
0.5	495

EPA Form 5770-7, “EPA Fellowship Activation Notice” 	152	1	0.5	76
0.5	76

EPA Form 5770-8, “Fellowship Agreement” 	152	1	1	152	1	152

EPA Form 5770-9, “EPA Fellowship Termination Notice” 	152	1	1	152	1
152

EPA Form 6600-01, “EPA Administrative and Financial Onsite Review
Questionnaire”	200	1	30	6,000	40	8,000

EPA Form 6600-06, “Certification Regarding Lobbying”	3,816	1	0.25
954	0.03	114

EPA Form 6600-08, "Lobbying Cost Certificate for Indirect Costs"	2,500	1
0.25	625	0.17	425

NCER Form 5, “Current and Pending Support”	1,300	1	0.5	650	0.25	325

SF-269, “Financial Status Report” - Family of Forms	3,417	2	0.5
3,417	2	13,668

SF-270, “Request for Advance or Reimbursement”  	475	4	1	1,900	1.5
2,850

SF-271, “Outlay Report and Request for Reimbursement for Construction
Programs” 	190	4	1	760	0.5	380

SF-272, “Federal Cash Transactions Report” (ACH Payment System) -
Family of Forms	105	4	2	840	2	840

SF-424, “Application for Federal Assistance” (including SF-424A,
SF-424B, SF-424C, and SF-424D)	3,816	1	4	15,264	5	19,080

SF-LLL, “Disclosure of Lobbying Activities” 	949	1	0.17	162	0	0

40 CFR 30.22 and 31.21 Establish separate bank account - ACH Payment
System	401	1	2	802	1	401

40 CFR 30.50 and 52 and 31.42 Keep records	3,417	1	5	17,085	1	3,417

40 CFR 30.50 and 52 and 31.42 Completion of desk review protocol	95	1	2
190	2	190

40 CFR 30.50 and 52 and 31.42 Completion of onsite protocol	340	1	2	680
2	680

40 CFR 30.50 and 52 and 31.42 Completion of project officer protocol	285
1	1	285	1	285

40 CFR 30.51 and 31.40 Submit progress reports	1,709	4	6.5	44,434	4
27,344

40 CFR 30.33 and 31.32 Report on Federally-owned property 	171	1	4	684	1
171

40 CFR 30.21 and 31.20 Maintain financial management system	3,417	1	2
6,834	1	3,417

Meet OMB Circular A-133 Audit Requirement	475	1	2	950	0	0

Total	38,524	42	81.17	114,531	74.70	87,265

EXHIBIT B

EPA GRANT FORMS

Forms covered in this ICR include:

EPA Form 6600-09, “EPA Administrative Capability Questionnaire”

EPA Form 4700-4, “Preaward Compliance Review Report for All Applicants
and Recipients Requesting Federal Financial Assistance”

EPA Form 5700-54, “Key Contacts Form,” and EPA Form 5700-55, “Key
Contacts Form for Multiple Principal Investigators”

EPA Form 5770-2, “Fellowship Application”

EPA Form 5770-3, “Fellowship Facilities and Commitment Statement”

 EPA Form 5770-4, “Fellowship Applicant Qualifications Inquiry”

EPA Form 5770-5, “Agency Fellowship Certification”

EPA Form 5770-7, “EPA Fellowship Activation Notice”

 EPA Form 5770-8, “Fellowship Agreement”

EPA Form 5770-9, “EPA Fellowship Termination Notice”

EPA Form 6600-01, “EPA Administrative and Financial Onsite Review
Questionnaire”

EPA Form 6600-06, “Certification Regarding Lobbying”

EPA Form 6600-08, “Lobbying Cost Certificate for Indirect Costs”

NCER Form 5, “Current and Pending Support”

SF-269, “Financial Status Report” – Family of Forms

SF-270, “Request for Advance or Reimbursement”

SF-271, “Outlay Report and Request for Reimbursement for Construction
Programs”

SF-272, “Federal Cash Transactions Report” – Family of Forms

SF-424, “Application for Federal Assistance”

SF-424A, “Budget Information - Non-Construction Programs”

SF-424B, “Assurances - Non-Construction Programs”

SF-424C, “Budget Information - Construction Programs”

SF-424D, “Assurances - Construction Programs”

SF-LLL, “Disclosure of Lobbying Activities”

EXHIBIT C

ENVIRONMENTAL PROTECTION AGENCY

FINANCIAL ASSISTANCE PROGRAMS—CATALOG OF

FEDERAL DOMESTIC ASSISTANCE (CFDA) NUMBER AND TITLE

Office of Air Radiation (OAR)

66.001		Air Pollution Control Program Support

66.032 	State Indoor Radon Program

66.033 	Ozone Transport

66.034 	Survey, Studies, Investigations, Demonstrations and Special
Purpose Activities Relating to the Clean Air Act

66.036	Clean School Bus USA

66.037	Internships, Training and Workshops for the Office of Air and
Radiation

66.038	Training, Investigations, and Special Purpose Activities of
Federally-Recognized Indian Tribes Consistent With the Clean Air Act
(CAA), Tribal Sovereignty and the Protection and Management of Air
Quality

66.039	National Clean Diesel Funding Assistance Program

66.040	State Clean Diesel Grant Program

Office of the Chief Financial Officer (OCFO)

66.202		Congressionally Mandated Projects

66.203		Environmental Finance Center Grants

Office of Small Business Programs (OSBP)

66.220		Academic Institutions Capacity Development Grants

Office of Enforcement and Compliance Assurance (OECA)

66.305	Compliance Assistance-Support for Services to the Regulated
Community and Other Assistance Providers

66.306	Environmental Justice Collaborative Problem-Solving Cooperative
Agreement Program

66.309	Surveys, Studies, Investigations, and Special Purpose Activities
Relating to Environmental

66.310	Capacity Building Grants and Cooperative Agreements for
Compliance Assurance and Enforcement Activities in Indian Country and
Other Tribal Areas

66.312	State Environmental Justice Cooperative Agreement Program

66.604		Environmental Justice Small Grants Program

66.700 	Consolidated Pesticide Enforcement Cooperative Agreements

66.701 	Toxic Substances Compliance Monitoring Cooperative Agreements

66.709 	Multi-Media Capacity Building Grants for States and Tribes

Office of Water (OW)

66.418		Construction Grants for Wastewater Treatment Works

66.419 	Water Pollution Control - State and Interstate Program Grants

66.424	Surveys, Studies, Demonstrations and Special Purpose Grants -
Section 1442 of the Safe Drinking Water Act

66.432 	State Public Water System Supervision

66.433 	State Underground Water Source Protection

66.436	Surveys, Studies, Investigations, Demonstrations, and Training
Grants and Cooperative Agreements - Section 104(b)(3) of the Clean Water
Act

66.437		Long Island Sound Program

66.439		Targeted Watersheds Grants

66.454 	Water Quality Management Planning

66.456 	National Estuary Program

66.458 	Capitalization Grants for Clean Water State Revolving Funds

66.460 	Nonpoint Source Implementation Grants

66.461 	Regional Wetland Program Development Grants

66.462	National Wetland Program Development Grants and Five-Star
Restoration Training Grant

66.463 	Water Quality Cooperative Agreements

66.466 	Chesapeake Bay Program

66.467 	Wastewater Operator Training Grant Program

66.468 	Capitalization Grants for Drinking Water State Revolving Funds

66.469 	Great Lakes Program

66.471	State Grants to Reimburse Operators of Small Water Systems for
Training and Certification Costs

66.472 	Beach Monitoring and Notification Program Implementation Grants

66.473 	Direct Implementation Tribal Cooperative Agreements

66.474 	Water Protection Grants to the States

66.475 	Gulf of Mexico Program

66.478 	Water Security Training and Technical Assistance and Water
Security Initiative Contamination Warning

66.479	Wetland Program Grants - State/Tribal Environmental Outcome
Wetland Demonstration Program

66.480		Assessment and Watershed Protection Program Grants

66.481		Lake Champlain Basin Program

66.926 	Indian Environmental General Assistance Program (GAP)

Office of Administration and Resources Management (OARM)

66.508 	Senior Environmental Employment Program

66.518		State Senior Environmental Employment Program

Office of Research and Development (ORD)

66.509		Science to Achieve Results (STAR) Research Program

66.510	Surveys, Studies, Investigations and Special Purpose Grants
within the Office of Research and Development

66.511	Office of Research and Development Consolidated
Research/Training/Fellowships

66.512	Regional Environmental Monitoring and Assessment Program (REMAP)
Research Projects

66.513	Greater Research Opportunities (GRO) Fellowships For
Undergraduate Environmental Study

66.514		Science to Achieve Results (STAR) Fellowship Program

66.515		Greater Research Opportunities (GRO) Research Program

66.516		P3 Award: National Student Design Competition for Sustainability

66.517		Regional Applied Research Efforts (RARE)

Office of Administration (OA)

66.605 	Performance Partnership Grants

66.609 	Protection of Children and Older Adults (Elderly) from
Environmental Health Risks

66.610	Surveys, Studies, Investigations and Special Purpose Grants
within the Office of the Administrator

66.611	Environmental Policy and Innovation Grants

66.940		Environmental Policy and State Innovation Grants

66.950 	Environmental Education and Training Program

66.951		Environmental Education Grants

66.952		National Network for Environmental Management Studies Fellowship
Program

Office of Environmental Information (OEI)

66.608	Environmental Information Exchange Network Grant Program and
Related Assistance

66.612	Survey, Studies, Investigations, Training Demonstrations and
Educational Outreach Related to Environmental Information and the
Release of Toxic Chemicals

Office of Prevention, Pesticides and Toxic Substances (OPPTS)

66.035		Community Action for a Renewed Environment (CARE) Program

66.707 	TSCA Title IV State Lead Grants Certification of Lead-Based
Paint Professionals

66.708 	Pollution Prevention Grants Program

66.714 	Pesticide Environmental Stewardship - Regional Grants

66.715 	Lead Educational Outreach and Baseline Assessment of Tribal
Children’s Exposure and Risk Associated With Lead

66.716	Research, Development, Monitoring, Public Education, Training,
Demonstrations, and Studies

66.717		Source Reduction Assistance

66.718		National Community-Based Lead Outreach and Training Grant
Program

Office of Solid Waste and Emergency Response (OSWER)

66.801 	Hazardous Waste Management State Program Support

66.802 	Superfund State Political Subdivision and Indian Tribe Site
Specific Cooperative Agreements

66.804 	State and Tribal Underground Storage Tanks Program

66.805 	Leaking Underground Storage Tank Trust Fund Program

66.806 	Superfund Technical Assistance Grants (TAG) for Community Groups
at National Priority List (NPL) Sites

66.808 	Solid Waste Management Assistance Grants

66.809 	Superfund State and Indian Tribe Core Program Cooperative
Agreements

66.810 	Chemical Emergency Preparedness and Prevention (CEPP) Technical
Assistance Grants Program

66.812 	Hazardous Waste Management Grant Program for Tribes

66.813	Alternative or Innovative Treatment Technology Research,
Demonstration, Training and Hazardous Substance Research Grants

66.814	Brownfields Training, Research and Technical Assistance Grants
and Cooperative Agreements

66.815		Brownfield Job Training Cooperative Agreements

66.816		Headquarter and Regional Underground Storage Tanks Program

66.817		State and Tribal Response Program Grants

66.818		Brownfields Assessment and Cleanup Cooperative Agreements

Office of International Affairs (OIA)

66.931	International Financial Assistance Projects Sponsored by the
Office of International Affairs

Region 1

66.110		Healthy Communities Grant Program

Region 3

66.113		Region 3 Environmental Priority Projects

Region 6

66.116		Regional Geographic Initiative/Environmental Priority Projects

Region 7

66.111		Regional Environmental Priority Projects

Region 8

66.112	Surveys, Studies, Investigations, Training, Demonstrations, and
Special Purpose Grants for Regional Geographic Initiatives

Region 9

66.117		Region 9 multi-media and geographic priority projects

66.600		Environmental Protection Consolidated Grants Program Support

Region 10

66.119		West Coast Estuaries Initiative

 $40.88 represents the average wage rate of several occupations expected
to apply for grants or fellowships.  This information is derived from
Bureau of Labor Statistics; Occupational Employment and Wages, May 2007.
 Costs were then updated to current levels. Cost data available at:
http://www.bls.gov/oes/current/oes_stru.htm (accessed 9/24/2008).  1.43
represents a 43% rate for benefits.  This figure is derived from the
Bureau of Labor Statistics’ “Table 1. Civilian Workers, by Major
Occupation Group; Management, Professional, and Related,” Employer
Costs for Employee Compensation – June 2008.”

  $16.51 represents the average hourly wage rate of two
administrative/clerical positions.	 This information is derived from
Bureau of Labor Statistics; Occupational Employment and Wages, May 2007.
 Costs were then updated to current levels.  Cost data available at:
http://www.bls.gov/oes/current/oes_stru.htm (accessed 9/24/2008).  1.43
represents a 43% rate for benefits.  This figure is derived from the
Bureau of Labor Statistics’ “Table 1. Civilian Workers, by Major
Occupation Group; Management, Professional, and Related,” Employer
Costs for Employee Compensation – June 2008.”

 Office of Personnel Management; 2008 General Schedule (GS) Base (Hourly
Rate) for GS 11, Step 9 ($29.22).  Available at:    HYPERLINK
"http://www.opm.gov/oca/08tables/pdf/gs_h.pdf"
http://www.opm.gov/oca/08tables/pdf/gs_h.pdf .  This was fully burdened
(x 40%), yielding a wage rate of $40.91.

  PAGE  1

A -  PAGE  1

 PAGE

B - PAGE   1

C - PAGE   1


Purity (other
contaminants)
Identity
Potency
Others (cell
dose)
Others (cell
viability)
Description of Test Methods
FINAL PRODUCT RELEASE CRITERIA/SPECIFICATIONS
Tabulation of Final Product Release Criteria Tests, Test Methods, Criteria, Test Sensitivity &
Specificity
Test
Method
Criteria
Sensitivity
Specificity
Results Available
Prior to Release
Description of Test Methods
PRODUCT STABILITY
In-Process Stability Testing
Cryopreserved Cells
Other Intermediate Holding Steps
Final Product Stability Testing
Product Formulation to Patient Infusion
Shipping Conditions
OTHER ISSUES
Product Tracking
38

Contains Nonbinding Recommendations
Labeling and Containers
In-Process Labeling
Final Product Labeling
Container Closure & Integrity
Environmental Impact
Validation and Qualification of the Manufacturing Process
QA/QC Program
Manufacturing Process Validation
Biostatistics
PRECLINICAL STUDIES
CLINICAL STUDIES
Protocol Title
Subject Population
Route of Administration
Dose
Frequency
Genetic, Biochemical, and Immunological Testing
Informed Consent
RECOMMENDATION
COMMENTS TO SPONSOR
Clinical Hold
Non-Clinical Hold
Signature
Date:____________________
Reviewer Name
39

Contains Nonbinding Recommendations
APPENDIX B – CONSIDERATIONS FOR DEVELOPMENT OF FINAL PRODUCT
RELEASE CRITERIA SPECIFICATIONS AND STABILITY PROTOCOLS
Specifications are the quality standards (i.e., tests, analytical procedures, and acceptance criteria)
that confirm the quality of products and other materials used in the production of a product.
Acceptance criteria are the numerical limits, ranges, or other criteria for the tests described.  For
additional information, see ICH Guideline Q6B:  “Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products”.
4
We believe that certain release specifications, such as
those related to product safety, should be in place prior to initiating Phase 1 clinical studies.  As
product development proceeds, additional specifications for product quality and manufacturing
consistency are developed and implemented.  For additional discussion of manufacturing quality
control, see “Guidance for Industry: Guideline on the Preparation of Investigational New Drug
Products” and “Guidance for Industry: IND Meetings for Human Drugs and Biologics;
5
Chemistry, Manufacturing and Controls Information”.
6
A.
Development of Release Acceptance Criteria
We recommend that proposed release acceptance criteria for the final product be based
on scientific data and manufacturing experience obtained during development of the
product as described below:
x
Phase 1 – Based on data from lots used in preclinical studies.
x
Phase 2 – Refine and tighten based on data generated during Phase 1.
x
Phase 3 – Based on information collected during product development.
x
Licensure – Based on information collected during product development
using validated assays.
B.
Development of Acceptance Criteria Analytical Procedures
We recommend that proposed analytical procedures be based on scientific data and
manufacturing experience as described below:
x
Phase 1-3 – Usually based on Code of Federal Regulation (CFR) methods
or alternative methods, if appropriate.
x
Phase 2 – If an alternative to the CFR method is used, we recommend that
the sponsor initiate validation of the alternative by Phase 3.
x
Licensure – The product specification should be in place and established
under a validated assay.
4
Guidance for Industry:  Q6B Specifications:  Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products, August 1999, http://www.fda.gov/cder/guidance/Q6Bfnl.pdf.
5
Guidance for Industry: Guideline on the Preparation of Investigational New Drug Products (Human and Animal),
dated March 1991, reprinted November 1992, http://www.fda.gov/cder/guidance/old042fn.pdf.
6
Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls
Information, May 2001, http://www.fda.gov/cber/gdlns/ind052501.htm
40

Contains Nonbinding Recommendations
C.
Development of Stability Protocols
In order to develop adequate stability data for timely submission in a license application,
we recommend that a sponsor implement and expand the stability program as described
below:
x
Phase 1 - 3 – Preliminary data on product stability must indicate whether
the product or components are likely to remain stable for the duration of
the clinical trial.  Note:  the regulations require that the IND contain these
data at each stage of the clinical trial (21 CFR 312.23(a)(7)(ii)).
x
Phase 2 – We recommend that the sponsor initiate a stability protocol to
accumulate additional data.
x
Phase 3 – We recommend that the sponsor begin to establish the dating
period, storage conditions, and shipping conditions based on data derived
from the stability protocol.
41


Federal Agency Occupational Safety and Health Training Survey Report

(June 2007)

Background

During the March 1, 2007 meeting of the Federal Advisory Council on
Occupational Safety and Health (FACOSH) Assistant Secretary Foulke
requested that a survey be conducted to assess the types of occupational
safety and health training utilized by federal agencies.  The OSHA
Training Institute (OTI) in conjunction with the OSHA Office of Federal
Agency Programs distributed an online survey to collect this
information.  The survey was sent to Designated Safety and Health
Officials (DASHOs) and safety and health managers at each federal
agency.  A total of 155 completed surveys were received.  Many agencies
submitted several responses as a result of the survey being forwarded to
sub-agencies and various agency establishments. Therefore, percentages
have been reported since they make more interpretive sense than actual
number of responses.

Types of Training Currently Provided Within Agencies

Respondents were asked to identify what types of occupational safety and
health training their agency provided top management officials,
supervisors, safety and health specialists, safety and health
inspectors, collateral safety and health personnel, and employees and
employee representatives.  These results are presented in TABLE 1.
Training developed “in house” emerged as the most common form of
training for each of these positions.  For top management officials and
safety and health inspectors an approximately equal amount of training
was provided through each of the other three methods.  OSHA developed
training materials were the second most utilized training method for
supervisors, collateral safety and health personnel, and employees and
employee representatives.  Safety and health specialists were provided
OSHA courses and presentations by OSHA trainers more often than OSHA
developed training materials.  Collateral duty safety and health
personnel received OSHA courses and presentations by OSHA trainers more
often than “Other” types of training methods, according to the
survey, whereas employees and employee representatives were provided
with more of the “Other” types of training.

TABLE 1: Types of Training Offered by Position

(Percent of Respondents Selecting Training Type)

POSITIONS	Training Developed “in house”	OSHA Developed Training
Materials	OSHA Courses or Presentations by OSHA Trainers	Other

Top Management	70.97%*	30.97%	27.74%	28.39%

Supervisors	75.48%	37.42%	21.94%	23.87%

S & H Specialists	56.77%	44.52%	49.68%	38.71%

S & H Inspectors	52.26%	41.94%	42.58%	41.94%

Collateral S & H Personnel	71.61%	43.23%	36.13%	29.03%

Employees & Employee Representatives	83.23%	36.77%	20.65%	25.16%

* Respondents were asked to select all training types that applied for
each position.  Therefore, training categories are not mutually
exclusive and totals will not equal 100 percent.

Most of those respondents who selected “Other” provided detailed
explanations.  Many who selected “Other” simply used the text box as
a place to clarify their selection of one of the other three training
choices.  Some respondents indicated that they did not know or were
unsure.  However, two distinct groups did emerge within the “Other”
responses.  The first group listed knowledge sharing methods such as
briefings, attending meetings and conferences where occupational safety
and health was discussed, and mentoring interactions between staff.
Although these methods did supply information, they were not formal
training methods.  The second group included training through
contractors, online courses, videos and other “off the shelf” media,
and agency training centers.  Courses offered by the National Safety
Council and American Society for Safety Engineers were frequently
referenced for safety and health specialists, in particular.  Finally, a
few agencies mentioned that they did not have safety and health
inspectors or specialists and therefore did not offer any training for
these positions.

Preferred Training Format

Survey respondents were also asked to identify their agency’s
preferred format for providing training to each of these positions.  As
displayed in TABLE 2, formal classroom training was the most preferred
method for safety and health specialists, safety and health inspectors,
and collateral safety and health personnel.  Audio/video conferencing
was the most preferred for top management officials.  In addition,
web-based learning on-demand was agencies’ preferred training format
for both the supervisors and employees and employee representatives
groups.  Although not the most preferred method, technology-enabled
learning received strong support for safety and health specialists.
Approximately one-quarter to one-third of respondents selected
self-study as a preferred method for each of the positions listed.
Finally, nearly half of respondents selected training through Field
Federal Safety and Health Councils (FFSHCs) as the preferred method for
safety and health specialists.  Additionally, approximately one-third of
respondents chose training through FFSHCs for safety and health
inspectors and collateral safety and health personnel.

TABLE 2: Preferred Training Format by Position

(Percent of Respondents Selecting Training Type)

POSITIONS	Formal Classroom	Audio/Video Conferencing	Web-based Learning
On-Demand	Technology-enabled Learning	Self-Study	Training through FFSHCs

Top Management	34.19%*	43.23%	36.13%	20.65%	23.87%	18.06%

Supervisors	41.94%	31.61%	48.39%	15.48%	24.52%	21.29%

S & H Specialists	61.29%	34.84%	34.19%	41.29%	34.84%	47.74%

S & H Inspectors	44.52%	20.00%	28.39%	27.10%	23.87%	36.13%

Collateral S & H Personnel	56.13%	23.87%	41.94%	27.74%	29.68%	34.84%

Employees & Employee Reps.	45.16%	22.58%	50.97%	18.06%	30.32%	23.23%

* Percentage represents the percent of respondents selecting that type
of training for that specific position.  Each training format-position
pair should be considered independent from all others.  Therefore,
neither row or column totals will equal 100%.

Sharing Existing Training and Developing New Training

Respondents were asked questions about their agency’s desire to have
OSHA provide more pre-packaged safety and health training.  Respondents
were also asked if their agency would be willing to share with OSHA the
training materials their agency has already developed or work with OSHA
to develop training materials.  As shown in TABLE 3, more than 50
percent of respondents would like OSHA to provide more pre-packaged
safety and health training materials for use by federal agencies.

TABLE 3: Sharing Existing Training and Developing New Training

(Percent of Respondents)

QUESTIONS	Yes

Like to have OSHA provide more pre-packaged Safety and Health Training
materials for use by Federal Agencies.	52.90%

Willing to share with OSHA the Safety and Health Training materials that
my Federal Agency has developed.	40.65%

Willing to work with OSHA to develop Safety and Health Training
materials for my own and other Federal Agencies.	45.81%

Many of the respondents who answered “Yes” listed specific types of
training they would like to have OSHA provide.  A list of these training
topics is presented in TABLE 4.  Several respondents also elaborated on
the format and context in which they would like to have the training
offered.  These specifications included web-based training that can be
completed on-line or downloaded, distance learning through webcasts,
training CDs, power point presentations and lesson plans that can be
used by agency trainers. A few respondents emphasized the need for the
training to be low cost or free and provide scheduling flexibility.  The
ability to generate certificates of training completion was also
suggested by one respondent.  Another respondent requested that more
safety and health training be generated specifically for office
environments.

TABLE 4: Training Topics Respondents Would Like to See OSHA Provide in
Pre-Packaged Format

Asbestos awareness		Bloodborne pathogens		Collateral duty specific
training

Conducting Inspections	Confined space entry		Construction safety

Driving safety	Energy control		Ergonomics

Fire Safety	HAZWOPER	Lockout/Tagout

Machine Guarding		Material Handling 	OSHA Regulatory Updates

Pandemic Flu	Personal Protective Equipment	Recordkeeping

Respiratory Protection	Shop Safety	Warehousing

TABLE 5 displays the number of respondents from each agency as well as
the percent of those respondents who answered in favor of OSHA providing
more pre-packaged training materials.

With the exception of the U.S. Department of Commerce (DOC), U.S.
Department of Homeland Security (DHS), and the U.S. Department of
Veterans Affairs (VA), the departments overwhelmingly supported this
suggestion with 50 percent or more of their respondents answering
“Yes.”  Independent agencies and those respondents who did not
identify themselves were more divided.

TABLE 5: Sharing Existing Training and Developing New Training –

Agency Breakdown

   RESPONDENTS

Wants more pre-packaged materials 	Willing to share what Agency has
developed.	Willing to work with OSHA to develop Training

DEPARTMENTS	No. of Agency Responses	Percent of Agency Respondents
Answering Yes	Percent of Agency Respondents Answering Yes	Percent of
Agency Respondents Answering Yes

U.S. Air Force	3	66.67%	100.00%	100.00%

U.S. Department of Agriculture	23	60.87%	60.87%	69.57%

U.S. Department of Commerce	7	28.57%	42.86%	42.86%

U.S. Department of Defense	13	69.23%	53.85%	69.23%

U.S. Department of Education	2	100.00%	100.00%	100.00%

U.S. Department of Health & Human Services	7	57.14%	28.57%	57.14%

U.S. Department of Homeland Security	3	33.33%	33.33%	33.33%

U.S. Department of Justice	2	100.00%	50.00%	50.00%

U.S. Department of Labor	1	100.00%	100.00%	100.00%

U.S. Department of State	3	100.00%	66.67%	100.00%

U.S. Department of the Army	7	42.86%	28.57%	42.86%

U.S. Department of the Interior	2	50.00%	50.00%	100.00%

U.S. Department of the Navy	7	71.43%	71.43%	71.43%

U.S. Department of the Treasury	3	66.67%	33.33%	33.33%

U.S. Department of Transportation	1	100.00%	100.00%	100.00%

U.S. Department of Veterans Affairs	32	43.75%	12.50%	12.50%

INDEPENDENT AGENCIES

Central Intelligence Agency	1	0.00%	0.00%	0.00%

Environmental Protection Agency	2	50.00%	50.00%	50.00%

Export-Import Bank	1	0.00%	0.00%	0.00%

Federal Deposit Insurance Corp	1	0.00%	0.00%	0.00%

Federal Energy Regulatory Commission	1	100.00%	100.00%	100.00%

General Services Administration	4	100.00%	75.00%	50.00%

NASA	1	100.00%	100.00%	100.00%

National Archives and Records Administration	1	100.00%	100.00%	100.00%

National Transportation Safety Board	1	0.00%	0.00%	0.00%

Peace Corp	1	100.00%	0.00%	100.00%

Social Security Administration	1	100.00%	100.00%	100.00%

Tennessee Valley Authority	1	100.00%	100.00%	0.00%

U.S. Agency for International Development	1	0.00%	0.00%	0.00%

U.S. Chemical Safety and Hazard Investigation Board	1	0.00%	0.00%	0.00%

U.S. Consumer Product Safety Commission	1	0.00%	0.00%	0.00%

U.S. Holocaust Memorial Museum	1	0.00%	0.00%	0.00%

U.S. Railroad Retirement Board	1	100.00%	0.00%	0.00%

NOT AVAILABLE	18	22.22%	22.22%	22.22%

GRAND TOTALS	155	52.90%	40.65%	45.81%

Survey results presented in TABLE 5 show that many of the departments
that responded would be willing to share their occupational safety and
health training.  DHS, U.S. Department of Health and Human Services
(HHS), DOA, U.S. Department of the Treasury (Treasury), and VA are
notable exceptions.  Independent agencies’ willingness to share their
OSH training was evenly mixed, and those agencies not providing
respondent identification were less willing.

In addition, nearly 46 percent of respondents answered “Yes” to
their agency’s willingness to work with OSHA to develop safety and
health training materials for their own agencies as well as other
federal agencies. TABLE 5 displays the percent of respondents who
indicated that their agency was willing to work with OSHA to develop
safety and health training materials for themselves and other federal
agencies.  The departments were overwhelmingly supportive with the
exception of DHS, Treasury and VA.  The independent agencies again had
mixed responses.  Those respondents who did not provide agency
identification information were less willing to work with OSHA in this
capacity.

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