67746 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 

ACTION: Notice of extension of 

application deadline.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

extension for acceptance of applications 

to its continuous marketing applications 

(CMA) Pilot 2 program implemented 

under the guidance for industry entitled 

‘‘Continuous Marketing Applications: 

Pilot 2–Scientific Feedback and 

Interactions During Development of Fast 

Track Products Under PDUFA.’’ The 

extension applies only to the Center for 

Drug Evaluation and Research (CDER) 

and the Center for Biologics Evaluation 

and Research (CBER) review divisions 

that have not received acceptable 

applications for participation in the 

Pilot 2 program.

DATES: Submit written or electronic 

comments on agency guidances at any 

time. FDA will accept applications 

through December 31, 2004, for 

participation in the CMA Pilot 2 

program per the restrictions described 

in the SUMMARY section of this 

document.

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, or the Office of 

Communications, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

either office in processing your request. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

John Jenkins, Center for Drug 

Evaluation and Research (HFD–

020), Food and Drug 

Administration, 5515 Security 

Lane, Rockville, MD 20852, 301–

594–3937, or

Robert A. Yetter, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852, 301–827–0373.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 6, 

2003 (68 FR 57696), FDA announced the 

availability of a guidance entitled 

‘‘Continuous Marketing Applications: 

Pilot 2–Scientific Feedback and 

Interactions During Development of Fast 

Track Products Under PDUFA.’’ This 

guidance is one in a series of guidance 

documents that FDA agreed to draft and 

implement in conjunction with the June 

2002 reauthorization of the Prescription 

Drug User Fee Act of 1992 (PDUFA). 

The guidance discusses how the agency 

will implement a CMA Pilot 2 program 

for frequent scientific feedback and 

interactions between FDA and 

applicants during the investigational 

phase of development for certain Fast 

Track drug and biological products.

Under the CMA Pilot 2 program, 

certain drug and biologic products that 

have been designated as Fast Track (i.e., 

products intended to treat a serious and/

or life-threatening disease for which 

there is an unmet medical need) are 

eligible to be considered for 

participation in the CMA Pilot 2 

program. The CMA Pilot 2 program is an 

exploratory program, and FDA will 

evaluate its impact on the 

investigational phase of drug 

development. Under the pilot program, 

a maximum of one Fast Track product 

per review division in CDER and CBER 

will be selected to participate. The 

guidance provides information 

regarding the selection of applications 

for the CMA Pilot 2 program, the 

formation of agreements between FDA 

and applicants on the investigational 

new drug (IND) communication process, 

and other procedural aspects of the 

CMA Pilot 2 program.

Per section III.A.4 of the guidance, 

applicants were originally asked to 

apply for participation in the CMA Pilot 

2 program from October 6, 2003, 

through December 8, 2003. For review 

divisions that had not received any 

acceptable CMA Pilot 2 program 

applications by December 8, 2003, 

applications were also accepted 

between February 9, 2004, and 

September 30, 2004. This notice further 

extends that deadline to December 31, 

2004, to ensure inclusive and relevant 

results from the CMA Pilot 2 program. 

A description of the application 

submission process, evaluation criteria, 

and selection process is in the guidance. 

Applications will be accepted only in 

CDER and CBER divisions that have not 

previously selected a Pilot 2 

application. Information regarding the 

CDER and CBER divisions that are 

available to select the CMA Pilot 2 

program application can be found on 

FDA’s Web site at http://www.fda.gov/

cder/pdufa/CMA.htm. For each of these 

divisions, the first application received 

that adequately meets the evaluation 

criteria will be accepted into the CMA 

Pilot 2 program and applicants will be 

informed within 6 weeks of application 

submission.

II. Electronic Access

Persons with access to the Internet 

can obtain the guidance at http://

www.fda.gov/cder/guidance/index.htm

or at http://www.fda.gov/cber/

guidelines.htm.

Dated: November 15, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–25799 Filed 11–17–04; 1:52 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0460]

Draft Guidance for Industry on Listed 

Drugs, 30-Month Stays, and Approval 

of ANDAs and 505(b)(2) Applications 

Under Hatch-Waxman, as Amended by 

the Medicare Prescription Drug, 

Improvement, and Modernization Act 

of 2003—Questions and Answers; 

Availability; Correction

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of November 4, 2004. This 

document announced the availability of 

a draft guidance for industry entitled 

‘‘Listed Drugs, 30-Month Stays, and 

Approval of ANDAs and 505(b)(2) 

Applications Under Hatch-Waxman, as 

Amended by the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003—Questions and Answers.’’

The document was published with an 

incorrect docket number. This 

document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Joyce A. Strong, Office of Policy (HF–

27), Food and Drug Administration, 

5600 Fishers Lane, Rockville MD 20857, 

301–827–7010.

SUPPLEMENTARY INFORMATION: In FR Doc. 

04–24675, appearing on page 64314 in 

the Federal Register of Thursday, 

November 4, 2004, the following 

correction is made:

1. On page 64314, in the second 

column, ‘‘Docket No. 2004N–0087’’ is 

corrected to read ‘‘Docket No. 2004D–

0460’’.

Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 67747

Dated: November 12, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–25647 Filed 11–18–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Best Practices for the Licensing of 

Genomic Inventions

AGENCY: National Institutes of Health, 

Public Health Service, Health and 

Human Services (HHS).

ACTION: Notice of proposed best 

practices for the licensing of genomic 

inventions; request for comments. 

SUMMARY: The Public Health Service’s 

(PHS) primary mission is to acquire new 

knowledge through the conduct and 

support of biomedical research to 

improve the health of the American 

people. PHS seeks to maximize the 

public benefit whenever PHS owned or 

funded technologies are transferred to 

the commercial sector. These best 

practices for the licensing of 

government-funded genomic inventions 

are recommendations to the intramural 

PHS technology transfer community as 

well as to PHS funding recipients.

DATES: Comments must be received no 

later than January 18, 2005.

ADDRESSES: Comments on the proposed 

best practices must be submitted to: Dr. 

Bonny Harbinger, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Blvd., Suite 325, 

Rockville, Maryland, 20852; telephone: 

(301) 594–7700; e-mail: 

harbingb@mail.nih.gov.

SUPPLEMENTARY INFORMATION:

Best Practices for the Licensing of 

Genomic Inventions 

Introduction 

The Public Health Service’s (PHS) 

primary mission is to acquire new 

knowledge through the conduct and 

support of biomedical research to 

improve the health of the American 

people. This mission is advanced by the 

intramural research efforts of 

government-owned and -operated 

laboratories and by the extramural 

research efforts funded through grants 

and contracts. PHS seeks to maximize 

the public benefit whenever PHS owned 

or funded technologies are transferred to 

the commercial sector. Motivated by 

this goal, we offer the following best 

practices for the licensing of 

government-funded genomic inventions. 

Genomic inventions include a wide 

array of technologies and materials such 

as cDNAs; expressed sequence tags 

(ESTs); haplotypes; antisense molecules; 

small interfering RNAs (siRNAs); fulllength genes and their expression 

products; as well as methods and 

instrumentation for the sequencing of 

genomes, quantification of nucleic acid 

molecules, detection of single 

nucleotide polymorphisms (SNPs), and 

genetic modifications. Much of the 

value associated with the commercial 

use of these technologies involves 

nucleic acid-based diagnostics, potential 

gene therapy applications, and the 

development of new DNA- and RNAbased therapeutics. 

Background 

Among the benefits derived from 

PHS-conducted and -supported 

biomedical research are effective and 

accessible new healthcare treatments 

and services. Practical realization of 

these benefits depends on the ability 

and willingness of private sector 

partners to develop and commercialize 

new technologies arising from PHS 

conducted and funded research. For 

potential preventive, diagnostic, and 

therapeutic products, the interest of the 

private sector in commercializing new 

technologies often depends on the 

existence of patent protection on the 

technology in the United States and 

foreign countries. 

The Bayh-Dole Act of 1980 allows 

PHS grantees and contractors to seek 

patent protection on subject inventions 

made using Government funds and to 

license those inventions with the goal of 

promoting their utilization, 

commercialization, and public 

availability. Recipients of PHS grants 

and contracts have a role in 

implementing the requirements of the 

Bayh-Dole Act (http://sedison.info.nih.gov/iEdison/

www.iedison.gov). In 1986, Federal 

laboratories, including PHS research 

laboratories at the National Institutes of 

Health (NIH), the Food and Drug 

Administration (FDA), and the Centers 

for Disease Control and Prevention 

(CDC), were given a statutory mandate 

under the Federal Technology Transfer 

Act (Pub. L. 99–502) and Executive 

Order 12591 to ensure that new 

technologies developed in those 

laboratories were transferred to the 

private sector and commercialized.

PHS recognizes that patenting and 

licensing genomic inventions presents 

formidable challenges for academic and 

government technology transfer 

programs because of the complexities in 

bringing these technologies to the 

marketplace in a way that balances the 

expansion of knowledge and direct 

public health benefit with the 

commercial needs of private interests. 

The following represents best 

practices recommendations to the 

intramural PHS technology transfer 

community as well as to universities, 

hospitals and other non-profit PHS 

funding recipients. These 

recommendations are not intended to 

constitute additional regulations, 

guidelines or conditions of award for 

any contract or grant, although they are 

consistent with existing policies set out 

in Sharing Biomedical Research 

Resources (http://ott.od.nih.gov/

NewPages/RTguide_final.html) and 

Developing Sponsored Research 

Agreements (http://ott.od.nih.gov/

NewPages/text-com.htm). 

Patent Protection 

Like other emerging technology areas, 

patents directed to genomic inventions 

tend to issue with claims that are broad 

in scope. Public health-oriented 

technology transfer must balance the 

rewards of broad intellectual property 

protection afforded to founders of 

enabling genomic inventions with the 

benefits of fostering opportunities for 

those striving to improve upon those 

innovations. 

Therefore, in considering whether to 

seek patent protection on genomic 

inventions, institutional officials should 

consider whether significant further 

research and development by the 

private sector is required to bring the 

invention to practical and commercial 

application. Intellectual property 

protection should be sought when it is 

clear that private sector investment will 

be necessary to develop and make the 

invention widely available. By contrast, 

when significant further research and 

development investment is not required, 

such as with many research material 

and research tool technologies, best 

practices dictate that patent protection 

rarely should be sought. 

Best Licensing Practices 

The optimal strategy to transfer and 

commercialize many genomic 

inventions is not always apparent at 

early stages of technology development. 

As an initial step in these instances, it 

may be prudent to protect the 

intellectual property rights to the 

invention. As definitive commercial 

pathways unfold, those embodiments of 

an invention requiring exclusive 

licensing as an incentive for commercial 

development of products or services can 

be distinguished from those that would 

best be disseminated non-exclusively in 

the marketplace.