Thursday 

October 14, 1993 

Part II 

i i 

Department of 

)Health and Human 

Services 

Food and Drug Administration 

Application of Current Statutory 

Authorities to Human Somatic Cell 

Therapy Products and Gene Therapy 

Products; Notice 
53248 Federal Register I Vol. 58, No. 197 I Thursday, October 14, 1993 I Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 93N--0173] 

Application of Current Statutory 

Authorltle.s to Human Somatic Cell 

Therapy Products and Gene Therapy 

Products 

AGENCY: Food and Drug Administration, 


HHS. 


ACTION: Notice. 


SUMMARY: The Food and Drug 

Administration (FDA) is making 

available, through this document, a 

statement of the manner in which FDA's 

current statutory authorities governing 

therapeutic products apply to human 

somatic cell therapy products and gene 

therapy products. FDA is publishing 

this statement in response to requests 

that the agency clarify its regulatory 

approach and provide guidance to 

manufacturers of products intended to 

be used in somatic cell therapy or gene 

therapy. As scientific knowledge in the 

area of somatic cell and gene therapy 

continues to accumulate and evolve, the 

agency's approach may also evolve. 

DATES: Submit written comments on the 

document by December 13, 1993. 

ADDRESSES: Submit written comments 

to the Dockets Management Branch 

(HFA-305), Food and Drug 

Adrrtinistration,rm. 1-23, 12420 

Parklawn Dr., Rockville, MD 20857. 

Submit investigational new drug 

applications (IND's) for somatic cell 

therapy and gene therapy products to 

the Division of Application Review and 

Policy (HFM-585), Office of 

Therapeutics Research and Review, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852-1448. Submit 

written requests for single copies of the 

document entitled "Points to Consider 

in Human Somatic Cell Therapy and 

Gene Therapy" to the Congressional and 

Consumer Affairs Branch (HFM-12), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852-1448, 301-295­

9000. Send two self-addressed adhesive 

labels to assist that office in processing 

requests. 

FOR FURTHER INFORMATION CONTACT: Ann 

Reed Gaines, Center for Biologics 

Evaluation and Research (HFM-£35), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852­

1448, 301-594-3074. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

As a consequence of scientific and 

biotechnological progress during the 

past decade, new therapies involving 

somatic cells and genetic material are 

being investigated, and commercial 

development of products for use in 

somatic cell therapies and gene 

therapies is occurring. Existing FDA 

statutory authorities, although enacted 

prior to the advent of somatic cell and 

gene therapies, are sufficiently broad in 

Scope t o encompass these new products 

and require that areas such as quality 

control, safety, potency, and efficacy be 

thoroughly addressed prior to 

marketing. Manufacturers and other 

interested parties have questioned FDA 

regarding how such products will be 

regulated. This statement outlines the 

current regulatory approach to products 

intended for use in somatic cell and 

gene therapies. 

II. Background 

A. Legal Authorities 

FDA regulates numerous kinds of 

products intended to prevent, treat, or 

diagnose diseases or injuries under legal 

authorities established in the Public 

Health Service Act (the PHS Act) and 

the Federal Food, Drug, and Cosmetic 

Act (the act). Section 351(a) ofthe PHS 

Act (42 U.S.C. 262(a)) identifies a 

biological product as "any virus, 

therapeutic serum, toxin, antitoxin, 

vaccine, blood, blood component or 

derivative, allergenic product, or 

analog_ous product, or arsphenamine or 

its derivatives (or any other trivalent 

organic arsenic compouod), applicable 

to the prevention, treatment, or cure of 

diseases or injuries of man." Section 

201(g)(l) ofthe act (21 U.S.C. 321(g)(l)) 

defines the term "drug," in part, as 

"articles intended for use in the 

diagnosis, cure, mitigation, treatment, or 

prevention of disease in mB.n or other 

animals." The term "device"-is defined 

in section 201(h) of the act, in part, as: • • •"an instnunent, apparatus, 

implement, machine, contrivance, implant. 

in vitro reagent, or other similar or related 

article * * * intended for use in the diagnosis 

of disease or other conditions, or in the cure, 

mitigation, treatment, or prevention of 

disease, in man or other animals, * * * which 

does not achieve its primary intended 

purposes through chemical action within or 

on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its 

p~ intended P!ll"Poses." 

Both the "drug" definition and the 

"device" definition also include ·articles 

"intended to affeq the strucllJle qi: a8.JI 

function ofthe body... 

Section 351(a) of the PHS Act requires 

premarket approval for biological 

products. Licenses are to be issued upon 

a showing that the establishments and 

products "meet standards, designed to 

insure the continued safety, purity, and 

potency of such products * * *." ( 42 

U.S.C. 262(d)). A biological product's 


effectiveness for its intended uses must 


be shown as part of the statutory 


requirement for potency (21 CFR 


600.3(s)). At the investigational stages, 


when the products are being studied in 


clinical trials to gather safety and 


effectiveness data, biological products 

must meet the requirements of part 312 

(21 CFR part 312). FDA's biologics 

regulations require the submission of 

both product license applications (PLA's) and establishment license 

applications (ELA's) (21 CFR 601.1 

through 601.10). Biologics 

establishments and products must 

satisfy detailed standards set forth in the 

regulations (21 CFR parts 600 through 

680). 

Section 351(b) of the PHS Act 

prohibits falsely labeling or marking a biological product. Under section 361 of 

the PHS Act (42 U.S.C. 264), the agency 

may promulgate regulations to prevent 

the introduction, transmission, or 

spread of communicable diseases. 

Products considered to be biological 

products subject to the provisions of 

section 351 ofthe PHS Act are 

simultaneously also drugs or devices 

subject to the applicable provisions 

under the act. For example, the 

adulteration, misbranding, and 

registration provisions ofthe act would 

apply to the product as a drug or device. 

Under section 501 of the act (21 

U.S.C. 351), both drugs and devices are 

considered adulterated for any of a 

number of specified reasons. Included 

among these adulteration provisions is 

the requirement that the methods and 

facilities and controls used for 

manufacture, processing, pai::king, and 

holding or installation conform with 

current good manufacturing practice 

(CGMP) regulations (21 U.S.C. 

351(a)(2)(B) and (b)). FDA's 

implementing regulations codified at 21 

CFR parts 211 and 820 specify the drug 

and device CGMP requirements. 

Section 502 ofthe act (21 U.S.C. 352) 

sets forth misbranding provisions that 

apply to drugs and devices. Among 

other circumstances, a drug or device is 

considered misbranded if the labeling is 

false or misleading or if the labeling 

fails to bear adequate directions for use or adequate warnings against unsafe use 

(21 U.S.C. 352(a) and (f)). Any drug or 

device is also misbranded ifit is 

danEerous to health when used in the · ·manner ·or witli i:he frequency sllggested 

in the labeling (21 U.S.C. 352(j)). For 

Prescription drugs and restricted 
Federal Register I Vol. 58, No. 197 I Thursday, October 14, 1993 I Notices 53249 

devices, section 502 of the act describes 

certain information that must be 

included in all advertisements or other 

printed material (21 U.S.C. 352(n) and 

(r)). FDA's regulations also establish 

labeling and advertising requirements in 

more detail (21 CFR parts 201, 202, and 

801). 

Section 510 of the act (21 U.S.C. 360) 

requires persons who own or operate 

establishments for the manufacture, 

preparation, propagation, compounding, 

or processing of drugs or devices (with 

certain exceptions) to register those 

establishments with FDA. Individuals 

who must register their establishments 

under section 510 of the act must also 

file a list of all the drugs and devices 

being made or processed at the 

establishment. FDA's registration 

regulations are codified at 21 CFR parts 

207 and 807. 

Although products regulated by FDA 

as biological products must also meet 

drug or device requirements, the agency 

does not require duplicate premarket 

approvals. For example, if FDA requires 

a PLA to be submitted for the product as a biologic, the agency does not also 

require submission of a new drug 

application (NDA) or a device premarket. 

approval application (PMA). 

The interstate commerce nexus 

needed to require premarket approval 

under the statutory provisions 

governing biologics and drugs may be 

created in various ways in addition to 

shipment of the finished product by the 

manufacturer. For example, even if a 

biological drug product is manufactured 

entirely with materials that have not 

crossed State lines, transport of the 

product into another State by an individual patient creates the interstate 

commerce nexus. If a component used 

in the manufacture of the product 

moves interstate, the interstate 

commerce prerequisite for the 

prohibition against drug misbranding is 

also satisfied even when the finished 

product Ste;lS within the State. Products 

that do not carry labeling approved in 

a PLA (or NDA) are misbranded under 

section 502(f)(l) of the act (21 U.S.C. 

352(f)(l); 21CFR201.5, 201.100(c)(2)). 

Moreover, falsely labeling a biological 

product is prohibited under section 

351(b) of the PHS Act without regard to 

any interstate commerce nexus (42 

U.S.C. 262(b)). The act contains a 

presumption of interstate commerce for 

devices (section 709 of the act (21 U.S.C. 

379a)). 

Both the PHS Act and the act provide 

authority for enforcement ofthe various 

statutory requirements. FDA is 

authorized to conduct inspections to 

determine compliance with regulatory 

requirements (42 U.S.C. 262(c) and 21 

U.S.C. 360(h) and 374). Approved 

PMA's may be suspended or revoked 

(42 U.S.C. 262(a) and 21 U.S.C. 355(e) 

and 360e(e)). Biological products and 

devices may be recalled under certain 

circumstances (42 U.S.C. 262(d)(2) and 

21 U.S.C. 360h). Judicial actions, 

including seizures, injunctions, and 

criminal prosecutions, may also be 

initiated (42 U.S.C. 262(f) and 21 U.S.C. 

332, 333, and 334). 

Some products may contain a 

combination of biological products and 

drugs or devices. Under a provision of 

the Safe Medical Devices Act of 1990, 

FDA determines the primary mode of 

action of the combination products (21 

U.S.C. 353(g)), then assigns the primary 

jurisdiction for review of the product 

within the agency based on that 

determination. FDA has established 

proced'1l:es for designating the 

organization within FD1' (i.e., the 

Center for Biologics Evaluation and 

Research (CBER), the Center for Drug 

Evaluation and Research (CDER), or the 

Center for Devices and Radiological 

Health (CDRH)) to review combination 

products or any other products where 

the agency center with primary 

jurisdiction is unclear (21 CFR 3.1 

through 3.10). CBER, CDER, and CDRH 

have also entered into intercenter 

agreements to clarify the centers' 

responsibilities for reviewing various 

kinds of products. 

B. Regulation of Somatic Cell and Gene 

Therapy Products 

This statement is intended to present 

the agency's current approach to 

regulating somatic cell and gene therapy 

products. For the purpose of this 

statement, somatic cell therapy products are defined as autologous (i.e., self), 

allogeneic (i.e., intra-species), or xenogeneic (i.e., inter-species) cells that 

have been propagated, expanded, 

selected, pharmacologically treated, or 

otherwise altered in biological 

characteristics ex vivo to be 

administered to humans and applicable 

to the prevention, treatment, cure, 

diagnosis, or mitigation of disease or 

injuries. Cellular products intended for 

use as somatic cell therapy are 

biological products subject to regulation 

pursuant to the PHS Act (42 U.S.C. 262) 

and also fall within the definition of 

drugs in the act (21 U.S.C. 321(g)). As 

biological products, somatic cell therapy 

products are subject to establishment 

and prodnct licensure to ensure product 

safety, purity, and potency. At the 

investigational stage, these products 

must be in compliance with part 312. 

Clinical trials are, therefore, to be 

conducted under JND's. As drugs, 

somatic cell therapy products are also 

subject to drug requirements such as 

conformity with CGMP regulations. 


FDA has not required premarketing 


approval for many types of 


transplantation, including bone marrow 

transplants. However, recent scientific 

and biotechnological developments now 

enable bone marrow to be manufactured 

into a somatic cell therapy product. 

Such products are subject to FDA 

regulation consistent with the approach 

to other somatic cell therapies described 

in this statement. In addition, other 

forms of transplantation, such as the 

transfer ofwhole organs and tissues, 

have been, or are currently being 

reassessed and addressed by FDA or 

other Federal agencies in light of current 

knowledge and technological advances. 

Gene therapy products are defined for 

the purpose of this statement as products containing genetic material 

administered to modify or manipulate 

the expression of genetic material or to 

alter the biological properties of living 

cells. Some gene therapy products (e.g., 

those containing viral vectors) to be 

administered to humans fall within the 

definition of biological products and are subject to the licensing provisions of the 

PHS Act, as well as to the drug 

provisions of the act. Other gene therapy 

products, such as chemically 

syothesized products, meet the drug 

definition but not the biological product 

definition and are regulated under the 

relevant provit!ions of the act only. 

Biological products intended for use 

as source materials for further 

manufacture into licensed somatic cell 

therapy prodncts or gene therapy 

products require premarketing approval 

as biological products intended for. 

further manufacture when they are 

shipped from one legal entity to 

another. Such products would be 

considered part of a shared 

manufacturing arrangement in which: 

(1) Two or more manufacturers perform 

different aspects of the manufacture of 

a product, (2) neither performs nor is 

licensed to perform all aspects of the 

manufacture, and (3) each manufacturer 

holds product and establishment license 

applications. In a shared manufacturing 

arrangement, FDA accepts only license 

applications for biological products 

intended for further manufacture that 

specify the licensed manufacturer or 

manufacturers to which the 

intermediate product will be shipped 

and approves such applications only 

after demonstration of safety and 

efficacy of the end product. For 

example, biological gene therapy 

products intended for use ex vivo in the 

manufacture of genetically altered cells 

for somatic cell therapies will require 

premarketing approval as biological 
53250 Federal Register I Vol. 58, No. 197 I Thursday, October 14, 1993 I Notices 

products intended for further 

manufacture when shipped from one 

legal entity to another and will be 

approved only when the final somatic 

cell therapy product is approved. For 

further discussion regarding shared 

manufacturing, refer to FDA's policy 

statement concerning cooperative 

manufacturing arrangements for 

licensed biological products, which was 

published in the Federal Register on 

November 25, 1992 (57 FR 55544). 

In accordance with the statutory 

provisions governing biological 

products and drugs, a somatic cell 

therapy product or gene therapy product 

must be the subject of an IND in 

compliance with part 312 or of an 

approved PLA regardless of whether the 

finished product is shipped across State 

lines. 

The manufacture of somatic cell 

therapy products or gene therapy 

products will involve many ancillary 

products used as part of the 

manufacturing process. The ancillary 

products are not intended-to be present 

in final products but may have an 

impact on the safety, purity, or potency 

ofthe products under manufacture. 

Such ancillary products meet the 

definition of devices and, ifmarketed, 

will be regulated under the act device 

authorities, with the appropriatetype of 

regulatory control being determined 

according to codified procedures (e.g., 

investigational device exemption 

(IDE)-21 CFR part 812; premarket 

approval (PMA)-21 CFR part 814; 

premarket notification (510(1<))-21 CFR 

870.81through807.97). When these 

ancillary products are used in the 

manufacturing of somatic cell or gene 

therapy products, they become subject 

to drug CGMP's, in particular for 

components and containers (21 CFR 

211.80 through 211.94 and 211. lOl(b) 

and (c)). 

Some of the ancillary products will 

already be marketed as medical devices, 

drugs, or biological products. When an 

ancillary product used as a component 

of the manufacturing process is 

marketed but not labeled for the specific 

use, such use may initially be described 

under the IND for the final somatic cell 

or gene therapy product. Such use of 

ancillary products by manufacturers of 

investigational somatic cell therapy or 

gene therapy products is contingent 

upon the submission of complete 

descriptions of the use of the ancillary 

product in the manufacturing process. 

Ifthe ancillary product used as a 

component of the manufacturing 

process does not have marketing 

approval, manufacturers ofthe somatic 

cell or gene therapy product must 

submit or provide cross-reference to a 

complete description of the 

manufacturing process, specifications, 

qualification, and acceptance criteria of 

the ancillary product. This information 

may be filed by the sponsor of the IND 

for the somatic cell or gene therapy 

product, may be filed in an IND or IDE 

by the manufacturer of an ancillary 

product, or may be made available by 

the manufacturer of the ancillary 

product in a master file format, as 

defined in 21CFR814.3(d) and 

discussed in 21CFR814.20(c). 

Manufacturers who wish to market 

ancillary products for use in the 

manufacturing of somatic cell or gene 

therapy products must file either: (1) A 

510(k), (2) a PMA, (3) en amendment to 

an existing 510(k), PMA, NDA, or PLA. 

The manufacture of somatic cell 

therapy products or gene therapy 

products may involve components of 

manufacture intentionally present as 

part of the final products. Products 

containing both a somatic cell 

component and another drug or device 

component in the final product will be 

handled as combination products. 

The following statement succinctly 

describes FDA's current approach to 

regulating somatic cell therapy and gene 

therapy products with primary 

emphasis on premarket approval issues. 

As previously discussed, products that 

meet the biologic, drug, or device 

definition must also comply with other 

relevant provisions of the PHS Act and 

the act. Manufacturers may also find 

useful information in FDA's document 

entitled "Points to Consider in Human 

Somatic Cell Therapy and Gene 

Therapy," Docket No. 91N-0428, 

available from CBER's Congressional 

and Consumer Affairs Branch (address 

above). · 

ill. Statement 

A. Somatic Cell Therapy 

1. Definition 

Somatic cell therapy is the 

prevention, treatment, cure, diagnoSis, 

or mitigation of disease or injuries in 

humans by the administration of 

autologous, allogeneic, or xenogeneic 

cells that have been manipulated or 

altered ex vivo. Manufacture of products 

for somatic cell therapy involves the ex 

vivo propagation, expansion, selection, 

or pharmacologic treatment of cells, or 

other alteration of their biological 

characteristics. 

2. Cells Subject To Licensure as Final 

Products When Intended for Use as 

Somatic Cell Therapy 

Cells subject to licensure as final 

biological products when intended for 

use as somatic cell therapy include cells 

manipulated in a way that changes the 

biological characteristics of the cell 

population (e.g., by expansion, 

selection, encapsulation, activation, or 

genetic modification as a part of gene 

therapy as defined in section ID.B.1. of 

this document). 

Examples include the following: (1) 

Autologous or allogeneic lymphocytes 

activated and expanded ex vivo (e.g., 

lymphokine-activated killer cells (LAK), 

tumor infiltrating lymphocytes (TIL 

cells), antigen specific clones); (2) 

encapsulated autologous, allogeneic, or 

xenogeneic cells or cultured cell lines 

intended to secrete a bioactive factor or 

factors (e.g., insulin, growth hormone, a 

neurotransmitter); (3) autologous or 

allogeneic somatic cells (e.g., 

hepatocytes, myocytes, fibroblasts, bone 

marrow- or blood-derived hematopoietic 

stem cells, lymphocytes) that have been 

genetically modified; (4) cultured cell 

lines; and (5) autologous or allogeneic 

bone marrow transplants using 

expanded or activated bone marrow 

cells. (For bone marrow products whose 

status is not clear, consult CBER.) 

3. Cells and Tissues Subject to 

Licensure as Source Material 

Cells and tissues subject to biological 

product licensure as source material 

include allogeneic or xenogeneic cells 

harvested by other than the final 

product license holder and intended for 

m_anufacture into a somatic cell product. 

Examples include the following: (1) 

Muscle cells removed from donors and 

shipped to a manufacturer for expansion 

into a muscle cell therapy, (2) animal 

cells harvested at an animal care facility 

and shipped to a manufacturer for 

encapsulation or other manufacturing 

steps into a somatic cell therapy, and (3) 

other human tissue harvested from 

donors end shipped to another legal 

entity for manufacture into a somatic 

cell therapy. 

4. Cells for Which Applications for 

Approval Prior to Marketing are not 

Presently Required 

Cells for which applications for 

approval prior to marketing are not 

required at the present time include the 

following: (1) Cell transplants not 

having the characteristics described in 

sections ID.A.2. and ID.A.3. of this 

document, and (2) minimally 

manipulated or purged bone marrow 

transplants. Examples include the 

following: (1) Allogeneic bone marrow 

transplantation employing ex vivo T cell 

purging with a monoclonal antibody 

approved for such purging, (2) 

autologous bone marrow transplantation 

employing BX vivo tumor cell purging 

by an approved agent, and (3) 
Federal Register I Vol. 58, No. 197 I Thursday, October 14, 1993 I Notices 53251 

autologous bone marrow transplantation 

employing bone marrow enriched for 

stem cells by immunoadherence. 

(However, extensive manipulation of 

bone marrow for the pmpose of 

obtaining purified stem cell populations 

would result in a somatic cell therapy 

subject. to licensure.) 

B. Gene Therapy 

1. Definition 

Gene therapy is a medical 

intervention based on modification of 

the genetic material of living cells. Cells 

may be modified ex vivo for subsequent 

administration or may be altered in vivo 

by gene therapy products given directly 

to the subject. When the genetic 

manipulation is performed ex vivo on 

cells that are then administered to the 

patient, this is also a type of somatic cell 

therapy. The genetic manipulation may 

be intended to prevent, treat, cure, 

diagnose, or mitigate disease or injuries 

in humans. 

2. Final Products Containing the Genetic 

Material Intended for Gene Therapy 

Final products containing the genetic 

material intended for gene therapy are 

regulated as biological products 

requiring PLA's (e.g., viral vectors 

containing genetic material to be 

transferred, ex vivo transduced cells and 

analogous products) or as drugs 

requiring NDA's (e.g., synthetic 

products) regardless of whether they are 

intended for use in vivo or ex vivo. 

Gene therapy products that are licensed 

biological products will be approved as 

biological products intended for further 

manufacture ifthey are intended to be 

used ex vivo during the manufacture of 

genetically altered cells. 

Examples include the following: (1) A 

synthetic polynucleotide sequence 

intended to alter a specific genetic 

sequence in human somatic cells after 

systemic administration is regulated as 

a drug requiring an NDA; (2) a rettoviral 

vector containing the adenosine 

deaminase (ADA) gene, intended to be 

administered intravenously to the 

patient, is regulated as a biological 

product requiring a PLA; and (3) a 

retroviral vector containing the ADA 

gene and intended to modify cells ex 

vivo is regulated as a biological product 

intended for further manufacture 

requiring a PLA. 

3. Viral Vector Systems Intended for 

Further Manufacture Into Final Products 

The manufacture and quality control 

of viral vector systems (i.e., not 

containing the complete- genetic 

material) that are designed to serve as 

the starting point for further 

manufacture into final products (i.e., 

insertion of additional genetic material 

into the vector) may be described in a 

drug master file. 

C, Ancillary Products Used during 

Production ofSomatic Cell Therapies 

Numerous products will be used 

during production of somatic cell 

therapy. Examples include the 

following: (1) Bioreactors and cell 

culturing systems, (2) components of 

culture media, (3) drug- or biologic-like 

components used to activate or 

otherwise change the biological 

characteristics of the cells, (4) certain 

antisense polynucleotides, and (5) 

agents used to purge or select or 

stimulate specific cell populations. A 

common characteristic ofthese products 

is that they are intended to act on the 

cells, rather than to have an 

independent effect on the patient. 

Additionally, the intended action of 

these products is not dependent upon 

incorporation into the somatic cell with 

maintenance ofthe products• structural 

or functional integrity. 

These products meet the definition of 

medical devices. They are regulated as 

devices, with the type of regulatory 

control being determined according to 

codified procedures. In contrast, 

products administered directly to 

patients or products whose function 

requires incorporation into the somatic 

cells with maintenance to some degree 

of structural or functional integrity (e.g., 

vil'al or other vectors containing genetic 

material to be used in gene therapy) are 

not considered ancillary products; 

rather, they are regulated as drugs or 

biological products. 

The center primarily responsible for 

regulating a particular device will be 

designated according to the current 

intercenter agreements. For example, 

according to the current agreement, 

CDER will regulate the synthetic 

antisense compounds, CBER will be 

responsible for monoclonal antibodybased purging agents, and CDRH will 

oversee the approval ofbioreactors. 

D. Combination Products 

Many somatic cell products 

administered to patients will be 

combinations of a biological product 

and a device or of a drug, a biological 

product, and a device. Examples 

include the following: (1) Encapsulated 

pancreatic islet cells secreting insulin, 

and (2) a device containing 

encapsulated cells secreting a 

neurotransmitter. The combination 

products for which the primary 

mechanism of action is that of the 

somatic cell therapy component will be 

regulated as biological products. 

IV. Comments 

FDA recognizes that somatic cell and 

gene therapy products constitute a new 

and emerging scientific area. The agency 

will review and consider written 

comments on the regulatory approach 

set forth in this notice. Any comments 

received will be considered in 

determining whether amendments to, or 

revisions of, the approach are 

warranted. Two copies of any comments 

should be submitted, except that 

individuals may submit one copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Comments 

received are available for public 

examination in the Dockets 

Managemont Branch (address above) 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: September 24, 1993. 

Michael R. Taylor, 

Deputy Commissioner for Policy. 

[FR Doc. 93--24938 Filed Hl--13--93; 8;45 am) 

BIWNG CODE 4160-01-F