35750 Federal Register / Vol. 60, No. 132 / Tuesday, July 11, 1995 / Notices
Matters To Be Discussed such as epidemiologic studies, health Evaluation and Research; Use of Pilot
surveillance, exposure and disease registries, Manufacturing Facilities for the
Agenda items will include options for
health education, substance-specific applied Development and Manufacture of
relationships between the tribes and
research, emergency response, and Biological Products; Guidance,
ATSDR and CDC regarding the study of preparation of toxicological profiles.
provides guidance by the Center for
health effects from past, current, or In addition, under an MOU signed in
Biologics Evaluation and Research
future releases of radioactive and December 1990 with DOE, the Department of
(CBER) to manufacturers of biological
hazardous materials into the Health and Human Services (HHS) has been
environment at Hanford, and proposed given the responsibility and resources for products to clarify the licensing
actions based on the findings of ATSDR conducting analytic epidemiologic requirements for the use of small scale
investigations of residents of communities in and pilot facilities for the development
and CDC health research and public
the vicinity of DOE facilities, workers at DOE and manufacture of biological products.
health activities.
facilities, and other persons potentially These facilities are sometimes
Agenda items are subject to change as
exposed to radiation or to potential hazards collectively referred to by industry as
priorities dictate.
from non-nuclear energy production and use.
pilot facilities. This guidance document
Contact Person for More Information HHS delegated program responsibility to is intended to provide increased
CDC.
Linda A. Carnes, Health Council flexibility for industry without
Advisor, ATSDR, E28, 1600 Clifton Purpose diminishing public health protection.
Road, NE., Atlanta, Georgia 30333, The purpose of this meeting is to receive ADDRESSES: Submit written comments
telephone 404/6390730, FAX 404/639 updates on issues related to the Technical to the Dockets Management Branch
0759. Steering Panel and declassification of DOE (HFA305), Food and Drug
documents; discuss issues and develop
Administration, rm. 123, 12420
Dated: June 30, 1995. approaches to Public Outreach activities with
Parklawn Dr., Rockville, MD 20857.
Carolyn J. Russell, ATSDR support; develop approaches to
Comments should be identified with the
Director, Management Analysis and Services ATSDR and CDC health studies and medical
Office, Centers for Disease Control and monitoring programs, and receive updates on docket number found in brackets in the
Prevention (CDC). the Hanford Thyroid Disease Project and heading of the document. Two copies of
Lowell Severs studies. all comments are to be submitted,
[FR Doc. 9516890 Filed 71095; 8:45 am]
except that individuals may submit one
BILLING CODE 416370M Matters to be Discussed copy. The comments received are
Agenda items include ATSDRs medical
available for public examination in the
monitoring options, ATSDRs planning for a
Citizens Advisory Committee on Public medical assistance program, current ATSDR Dockets Management Branch between 9
Health Service Activities and Research health assessment activities. The a.m. and 4 p.m., Monday through
at Department of Energy (DOE) Sites: subcommittee will solicit concerns which Friday.
Hanford Health Effects Subcommittee they will ask ATSDR and CDC to address. FORFURTHERINFORMATIONCONTACT: Jean
Agenda items are subject to change as M. Olson, Center for Biologics
In accordance with section 10(a)(2) of priorities dictate. Evaluation and Research (HFM630),
the Federal Advisory Committee Act Contact Person for More Information Food and Drug Administration, 1401
(Pub. L. 92463), the Agency for Toxic Rockville Pike, suite 400 South,
Linda A. Carnes, Health Council Advisor,
Substances and Disease Registry Rockville, MD 208521448, 301594
ATSDR, E28, 1600 Clifton Road, NE,
(ATSDR) and the Centers for Disease Atlanta, Georgia 30333, telephone (404) 639 3074.
Control and Prevention (CDC) announce
0730, FAX (404) 6390759. SUPPLEMENTARYINFORMATION: CBER
the following meeting.
Dated: June 30, 1995. recognizes that development of
Name: Citizens Advisory Committee on Carolyn J. Russell, important new biological products is
Public Health Service Activities and Director, Management Analysis and Services expensive and time consuming, and that
Research at DOE Sites: Hanford Health Office, Centers for Disease Control and companies must be able to forecast and
Effects Subcommittee.
Prevention (CDC). evaluate their expenditures for this
Times and Dates: 8 a.m.5:30 p.m., July 27,
1995; 7 p.m.8 p.m., July 27, 1995; 8 a.m. [FR Doc. 9516889 Filed 71095; 8:45 am] process. Constructing a new facility to
manufacture a product that has not been
3:30 p.m., July 28, 1995. BILLING CODE 416370M
Place: Red Lion Inn, 2525 North 20th, fully tested in clinical trials could result
Pasco, Washington 99301, telephone (509) in a company being unable to recover a
5470701, FAX (509) 5474278. Food and Drug Administration major capital expenditure if the product
Status: Open to the public, limited only by is not ultimately brought to market.
the space available. The meeting room [Docket No. 95D0164] CBER also recognizes that for some
accommodates approximately 150 people. companies the best financial option may
FDA Guidance Document Concerning
Background Use of Pilot Manufacturing Facilities be the use of a pilot facility where a
product may be manufactured at a
A Memorandum of Understanding (MOU) for the Development and Manufacture
was signed in October 1990 and renewed in of Biological Products; Availability smaller scale than would be ultimately
November 1992 between ATSDR and DOE. desired for an approved product.
The MOU delineates the responsibilities and AGENCY: Food and Drug Administration, While CBER does not object to the use
procedures for ATSDRs public health HHS. of pilot production facilities for the
activities at DOE sites required under ACTION: Notice. manufacture of clinical material, many
sections 104, 107, and 120 of the companies are concerned that these
Comprehensive Environmental Response, SUMMARY: The Food and Drug facilities would not be eligible for
Compensation, and Liability Act (CERCLA or
Administration (FDA) is announcing the establishment licensure. This guidance
Superfund). These activities include health
availability of a guidance document document is intended to clearly
consultations and public health assessments
concerning the use of pilot facilities for articulate that pilot facilities are eligible
at DOE sites listed on, or proposed for, the
Superfund National Priorities List and at the development and manufacture of for licensure. The guiding principle is
sites that are the subject of petitions from the biological products. The guidance that an application for establishment
public; and other health-related activities document, entitled Center for Biologics licensure can be made for any facility Federal Register / Vol. 60, No. 132 / Tuesday, July 11, 1995 / Notices 35751
(regardless of the scale of manufacture) This guidance document is not financial option may be the use of a pilot
which is fully qualified, validated, binding on either FDA or manufacturers facility where a product may be
operates in accordance with current of biological products and does not manufactured at a smaller scale than might
be eventually desired for an approved
good manufacturing practices (CGMPs), create or confer any rights, privileges, or
product. While CBER has not objected to the
and otherwise complies with applicable benefits for or on any person.
use of pilot facilities for the manufacture of
law and regulations. In order to further Interested persons may submit to the
clinical material (provided such manufacture
streamline the approval process, the Dockets Management Branch (address is in compliance with requirements
agency is currently considering above) written comments on the applicable to investigational drugs), many
changing its procedures to eliminate the guidance document. Received companies are concerned that these facilities
requirement for a separate establishment comments will be considered to and the product manufactured in them
license for certain well defined classes determine if further revision to the would not be eligible for licensure. An
of biologic products. Because of recent guidance document is necessary. application for establishment licensure can
be made for any facility (regardless of the
scientific advances, both in methods of The title and text of the guidance
scale of manufacture) that has been fully
manufacture and in methods of analysis, document follows:
qualified and validated, that operates under
some products developed through
Center for Biologics Evaluation and CGMPs, and that otherwise complies with
biotechnology can be characterized in Research; Use of Pilot Manufacturing applicable laws and regulations. This
ways not historically considered Facilities for the Development and guidance document describes the conditions
possible. Thus, the agency is Manufacture of Biological Products; and procedures for submitting such
considering allowing biotech Guidance application(s) and for subsequent, optional
products that are well characterized to transfer of product manufacturing to a
be regulated under a single application. I. Introduction different manufacturing facility.
The agency plans to hold a scientific Biological products, which generally III. Guidance
include vaccines, blood and blood products,
conference in the fall of 1995, to
allergenic extracts, and biological The following provides information on the
develop a definition of well therapeutics, are regulated under section 351 submission of product license applications
characterized products that may be of the Public Health Service Act (the PHS (PLAs) and establishment license
amenable to regulation under new Act) (42 U.S.C. 262), as well as the Federal applications (ELAs) and investigational new
procedures. Food, Drug, and Cosmetic Act (21 U.S.C. drug applications (INDs) for products
This guidance document describes the 321). The PHS Act requires that biological manufactured in a pilot facility.
conditions and procedures for products be propagated or manufactured and 1. Use of a product manufactured in a pilot
submitting establishment license prepared at an establishment holding an facility in clinical trials conducted to
applications (ELAs) for pilot facilities unsuspended and unrevoked license. Lack of demonstrate safety and effectiveness and
and for subsequent transfer of product clarity about licensing requirements has led optional transition to a different facility.
manufacturing to a different facility. some applicants to make major investments INDs for all products should include
The guidance document provides in large scale manufacturing facilities before information that describes where the material
information concerning: (1) Use of a initiating the clinical trial(s) necessary to for the clinical trial(s) used to demonstrate
product manufactured in a pilot facility demonstrate the safety and effectiveness of safety and effectiveness is or was
their products. Such investments can result manufactured. Data submitted in support of
in clinical trials conducted to
in significant financial loss if the product is licensure of a biological product can be
demonstrate safety and effectiveness not ultimately brought to market. In this obtained using a product manufactured in a
and optional transition to a different document, the Center for Biologics pilot facility. In the event that a product
facility; (2) submissions for approval to Evaluation and Research (CBER) is providing manufactured in new facilities and/or scaled-
use a pilot facility for manufacture of a guidance to manufacturers and developers of up processes or facilities is intended to be
product; (3) submissions for approval to biological products to clarify licensing used at a later date for either completion of
use a different manufacturing facility procedures for the use of pilot facilities for the clinical trial(s) demonstrating safety or
while a product license application the manufacture of biological products. CBER effectiveness or for licensable product, the
(PLA) for a product manufactured in a considers a pilot production to be a time tables, new locations, and processes
procedure and facility fully representative of should be identified in the IND. A protocol
pilot facility and an ELA for a pilot
and simulating that to be applied on a full for comparing products should also be
facility are pending; (4) submissions for
commercial scale. For example, the methods submitted. Data which compares a product
approval to use a different of cell expansion, harvest, and product made in a new facility or with new processes
manufacturing facility when a product purification should be identical except for to a product used in earlier clinical studies
and pilot facility are currently licensed; scale of production. These facilities are should be submitted to the IND before
and (5) submission of a PLA based on sometimes collectively referred to by including the new product in the clinical
data obtained from a product made in a industry as pilot facilities and will be trial(s). If the product made in the new
pilot facility when licensure of the referred to as pilot in this document. These facility or by the new process will not be
product manufactured in the pilot facilities are to be distinguished from used in the clinical trials used to demonstrate
facility and of the pilot facility is not facilities used in research and development safety or effectiveness, the data comparing
that may not operate under appropriate the two products should be submitted in the
sought.
current good manufacturing practices IND, PLA, or PLA supplement. A description
The guidance also addresses review
(CGMPs). of any manufacturing changes that were
timeframes and submission times,
product consistency, data comparing II. Background made as a result of using a new facility or
new processes and stability data should also
products made in different facilities, CBER recognizes that development of be submitted to the IND or PLA as
and product availability at the time of important new biological products may be appropriate.
product licensure. expensive and time consuming and that
In addition, FDA intends to revise the companies must be able to forecast and 2. Submissions for approval to use a pilot
evaluate their expenditures for this process. facility for manufacture of a product.
policy statement entitled
Constructing a large scale facility to Information and data submitted in the PLA
Manufacturing Arrangements for
manufacture a product that has not been fully should be obtained using a product
Licensed Biologics published in the
tested in clinical trials could result in a major manufactured in the pilot facility. The ELA
Federal Register of November 25, 1992 capital loss if delays occur or the product is should include a completed Form FDA 3210;
(57 FR 55544) to accommodate these not ultimately brought to market. CBER also Application for Establishment License for
procedures. recognizes that for some companies, the best Manufacture of Biological Products (FDA 35752 Federal Register / Vol. 60, No. 132 / Tuesday, July 11, 1995 / Notices
Form 3210), which describes the pilot could be used in other clinical trials but application to be grounds for issuing a not
facility. If the facility is already licensed, an could not be marketed. CBER intends to approvable letter to the applicant.
ELA supplement that contains information review the ELA for the new facility within 5. Submission of a PLA based on data
specific to the new product should be new application timeframes under the obtained from a product made in a pilot
submitted. The facility and equipment, managed review process. As such, CBER facility when licensure of the product
regardless of scale, should have undergone intends to issue a new reference number and manufactured in the pilot facility and pilot
appropriate qualification and validation and review priority applications within 6 months, facility is not sought.
should be in compliance with applicable standard applications within 12 months, and
regulations, including, but not limited to, 21 supplements within 6 months. CBER intends CBER will allow submission of a PLA
CFR parts 210, 211, 600 and 820. A pre- to review the new PLA filing within 6 based on data obtained from clinical trials
license inspection will be conducted prior to months. An inspection of both facilities will using a product made in a pilot facility when
the approval of the PLA and ELA or ELA be performed if the applicant requests the pilot facility is not intended to be
supplement. The PLA and ELA may be licensure of both. Applicants should specify licensed. In order to verify data comparing a
submitted at different times, provided a product made in a pilot facility and used in
which establishment is a higher priority for
statement is included in any PLA or ELA the clinical trials to a product made in the
licensure and CBER may choose to
submission confirming that the facility is facility to be licensed, the pilot facility
concentrate its resources on reviewing the
ready for inspection and indicating the should be available for inspection up to the
application for that facility first. Either
approximate date for the companion time the applicant obtains licensure of the
combination of product and establishment
application submission. CBER intends to product in the new facility. A product used
may be licensed when all information has
review PLAs and ELAs submitted at in clinical trials to support licensure can be
been reviewed and found to be acceptable.
different times under the normal timeframe made in a facility for which the applicant
The pilot facility and product may be eligible
targets of the managed review process (from does not intend to seek licensure, but only
for licensure before the new facility and
the date of receipt at CBER, 12 months for a licensed product made in a licensed facility
product are ready for approval. In regard to
standard applications, 6 months for priority may be marketed. The PLA should contain
the timing of submissions, it should be noted
applications, and 6 months for supplements). information and data on a product
Because CBER issues the ELA and PLA that CBERs timeframe for review of a new manufactured in the pilot facility and a
concurrently, timing of submission of the ELA may be longer (12 months for standard statement that the pilot facility is ready for
companion applications should be carefully application and 6 months for priority inspection at the time of submission. An
considered. CBER intends to consider failure application under the managed review inspection of the pilot facility may be
to submit a companion application within 6 process) than that for review of the new PLA performed in some cases. Stability data from
months of receipt of a standard application filing. CBER intends to consider failure to a product made in the pilot facility, if
or 3 months of receipt of a priority submit a companion application within 6 representative of a product manufactured in
application to be grounds for issuing a not months of receipt of a standard application the facility intended to be licensed, can be
approvable letter to the applicant. or 3 months of receipt of a priority used in support of a proposed dating period.
application to be grounds for issuing a not A separate, original ELA for the facility
3. Submissions for approval to use a different approvable letter to the applicant. intended for licensure may be submitted
manufacturing facility while a PLA for a
4. Submissions for approval to use a different concurrently with the PLA or after review of
product manufactured in a pilot facility and
manufacturing facility when a product and the PLA has begun. The ELA for the facility
an ELA for a pilot facility are pending.
pilot facility are currently licensed. intended for licensure should be submitted
In this case, a PLA for a product made in when a product in support of approval has
A supplement to the approved PLA for a
a pilot facility and ELA for the pilot facility been manufactured, a product is available for
product made in a pilot facility and an ELA
are under review as outlined in section III. review, and the facility is ready for
or ELA supplement for the new facility
2 of this guidance. FDAs inspection of the inspection. If submission of the ELA occurs
should be submitted when the applicant
pilot facility may or may not have occurred. after PLA review has begun, an
wishes to obtain licensure for a different
The applicant is now requesting licensure of accompanying PLA supplement containing
facility and product manufactured in it. The
a different facility in addition to, or in lieu data comparing products made in both
of, licensure of the pilot facility. The PLA supplement should contain information facilities should include stability data,
following information should be submitted to on a product manufactured in the new process validation, and a description of any
the pending PLA: a description of facility, including a description of manufacturing changes (see Guidance (60 FR
manufacturing changes which have occurred, manufacturing changes that have occurred. 17535)). CBER intends to review each ELA
data comparing products made in the new (See Changes to be Reported for Product and and PLA under the current timeframe targets
and old facilities, and documentation of Establishment License Applications; of the managed review process (from the date
process validation and stability data for a Guidance (60 FR 17535, April 6, 1995)). of receipt at CBER, 12 months for standard
product manufactured in the new facility. Data comparing products made in each and 6 months for priority applications; 6
CBER intends to consider the submission to facility, and process validation and stability months for manufacturing supplements).
be a separate PLA filing that will be assigned data for a product manufactured in the new While an ELA and PLA need not be
a new reference number and a 6-month facility should also be provided. If a new submitted concurrently, applicants are
review timeframe. A new ELA that contains ELA is submitted, it should contain a reminded that CBER intends to approve
a completed ELA Form 3210 describing the completed ELA Form 3210 that describes the ELAs and PLAs concurrently. CBER intends
new facility should also be submitted. If the new facility. If the proposed facility is to consider failure to submit a companion
new facility is already licensed, the applicant already a licensed facility, an ELA application within 6 months of receipt of a
should submit a supplement to the approved supplement should be submitted that standard application or 3 months of receipt
ELA with the information specific to the new contains information specific to the new of a priority application to be grounds for
product. A statement confirming that the new product. A statement confirming that the issuing a not approvable letter to the
facility is ready for inspection should be facility is ready for inspection should be applicant.
included in the new PLA filing and the ELA included with each submission. CBER
or ELA supplement at the time of intends to review PLAs, ELAs, and 6. Demonstration of product consistency and
submission. Concurrent review of the pilot supplements according to the timeframe data comparing products made in different
facility will continue unless the applicant is targets of the managed review process (6 facilities.
no longer requesting approval to market lots months for manufacturing and facility When manufacture of a product is
manufactured in the pilot facility. If the changes) and intends to approve ELAs and transferred from a pilot facility to a different
applicant does not wish to pursue licensure PLAs or supplements concurrently, when all facility, a demonstration of product
of lots made in a pilot facility, a request may information has been reviewed and found consistency, data comparing the two
be made in writing that the pending ELA for acceptable. CBER intends to consider failure products, and process validation should be
the pilot facility be withdrawn; however, to submit a companion application within 6 submitted in the PLA supplement or
FDA may still conduct an inspection. In this months of receipt of a standard application amendment to the IND. Retention samples
case, lots manufactured in the pilot facility or 3 months of receipt of a priority from the pilot facility should be stored under Federal Register / Vol. 60, No. 132 / Tuesday, July 11, 1995 / Notices 35753
controlled conditions in sufficient quantity to Offices of Therapeutics Research and Review, wishes to make. The information from
conduct the side-by-side testing of products. Blood Research and Review, or Vaccines the responses will be summarized
Applicants are encouraged to discuss with Research and Review, or the Division of annually and the results used to
CBER what data are necessary to compare Establishment Licensing.
improve NBS products and services.
products, as such data may range from
8. Availability of product at the time of Copies of the final report of the
analytical testing to full clinical trial(s).
licensure summarized information will be
7. Review timeframes and submission times
If an applicant requests licensure for a pilot provided to NBS clients. This process
There may be cases where applicants wish facility, this choice may affect the amount of and report will allow NBS to comply
to submit an ELA for a pilot facility prior to product available at the time of approval. For with Executive Order 12862 and the
submitting a companion PLA. A statement important new products for use in treating
Government Performance and Results
that the facility is ready for inspection at the serious and life-threatening illnesses, the
Act (44 U.S.C. Chapter 35)
time of submission should be included. FDA ramifications of limited availability of the
ordinarily intends to inspect at the time the product at the time of approval should be Bureau Form Number: None
facility is manufacturing the product for assessed by the applicant. Frequency: Annually
which licensure is sought. It is possible that, Description of Respondents: Federal
in some cases, inspection of the Dated: June 26, 1995. government officials and secondarily
establishment could take place before the William B. Schultz, state and local government officials
submission of the PLA. It is also possible for Deputy Commissioner for Policy. engaged in policy making, regulation,
the ELA to be submitted after the PLA as
[FR Doc. 9517022 Filed 7795; 10:53 am] or management of public trust lands
discussed above.
CBER intends to review PLAs and ELAs BILLING CODE 416001F and resources
Estimated Completion time per
submitted at different times under the normal
timeframe targets of the managed review Respondent: 0.17 Hour
process (from the date of receipt at CBER, 12 DEPARTMENT OF THE INTERIOR Individuals invited to Respond
months for standard and 6 months for annually: 2000
priority applications; 6 months for National Biological Service Estimate annual Responses: 300
supplements). CBER intends to issue the Annual Burden Hours: 50
appropriate action letter (approved, Information Collection Submitted to Bureau Clearance Officer: Don Minnich,
approvable, or not approvable) to complete the Office of Management and Budget (202) 4824838
its action on any application. for Review Under the Paperwork
Applicants should be aware that Dated: June 23, 1995.
Reduction Act
submitting the ELA and PLA at separate F. Eugene Hester,
times will not necessarily reduce the The proposal for the collection of Deputy Director.
approval time when compared to concurrent information listed below has been [FR Doc. 9516901 Filed 71095; 8:45 am]
submission. Early submission of applications
submitted to the Office of Management
may, however, allow earlier feedback from BILLING CODE 4310DPM
and Budget for approval under the
CBER on deficiencies in an application that
provisions of the Paperwork Reduction
can be addressed by the applicant sooner
than would otherwise be possible. In all Act (44 U.S.C. Chapter 35). An INTERSTATE COMMERCE
cases described above, CBER intends to expedited review has been requested in COMMISSION
approve PLAs, ELAs, or supplements accordance with the Act so that
concurrently. approval can be received by August 18, [Finance Docket No. 32681]
In cases of shared manufacturing 1995, permitting the National Biological
arrangements (see 57 FR 55544 at 55545), the H. Peter Claussen and Linda C.
Service to comply with Executive Order
PLAs for the intermediate product(s) and ClaussenContinuance in Control
12862 reporting requirements for 1995.
end product should be submitted ExemptionGeorgia & Florida
Copies of the proposed collection of
concurrently in order for a complete review Railroad Co., Inc.
of the product to occur, since determining information and related forms may be
the approvability of the end product will obtained by contacting the Services AGENCY: Interstate Commerce
depend upon information in the intermediate clearance officer at the phone number Commission.
product PLAs. The ELAs may be submitted listed below. Comments and suggestions
ACTION: Notice of exemption.
at different times from the PLAs. on the proposal should be made directly
Applicants should consider carefully the
to the bureau clearance officer and the SUMMARY: The Commission under 49
consequences of the timing of any
Office of Management and Budget, U.S.C. 10505 exempts from the prior
submission on the use of CBER resources. It
is expected that applicants will use the Paperwork Reduction Project, approval requirements of 49 U.S.C.
flexible submission times in cases of need. Washington, DC 20503, telephone (202) 11343, et seq., the continuance in
Applicants should recognize that the filing of 3957340. control by H. Peter Claussen and Linda
submissions which are premature or Title: Generic Clearance for C. Claussen (the Claussens) of the
incomplete will result in unnecessary Measurement of Client Satisfaction Georgia & Florida Railroad Co., Inc.
resource commitments by CBER and the with National Biological Service (G&F), upon G&F becoming a rail
applicant. It is therefore recommended that
Products and Services carrier, subject to standard labor
applicants do not submit an ELA before
Abstract: The National Biological protective conditions. The Claussens
favorable preliminary data or information
from clinical trials of the product is available. Service (NBS) is initiating a process presently control Albany Bridge
For products intended for use in serious and with standard form to gather Company, Inc.; Gulf and Ohio Railways,
life-threatening diseases, applicants should information about its customers level Inc., which operates the Mississippi
consider submitting the ELA and PLA of satisfaction with its products and Delta Railroad and the Atlantic & Gulf
concurrently to prevent a situation from services. When certain NBS products Railroad; Wiregrass Central Railroad
occurring where otherwise approvable and services are delivered to a client, Company, Inc.; H&S Railroad Company,
product cannot be approved because the
the client will also be given a Client Inc.; Piedmont & Atlantic Railroad Co.,
facility is not yet ready to be licensed.
Response sheet on which the client is Inc.; and Rocky Mount & Western
If a scenario exists that is not covered in
this guidance document, the applicant invited to rate his/her satisfaction Railroad Co., Inc. G&F filed a notice of
should seek guidance by contacting the with the product or service and offer exemption in Finance Docket No. 32680
appropriate applications division in the any additional comments he/she to exempt its acquisition, lease, and