Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 28495 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0278] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Continuous Marketing 

Applications: Pilot 2—Scientific 

Feedback and Interactions During 

Development of Fast Track Products 

Under the Prescription Drug User Fee 

Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 20, 

2007. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. All comments should be 

identified with the OMB control number 

0910–0518. Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Liz 

Berbakos, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857,301–827–

1482. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on Continuous 

Marketing Applications: Pilot—

Scientific Feedback and Interactions 

During Development of Fast Track 

Products Under the Prescription Drug 

User Fee Act (OMB Control Number 

0910–0518)—Extension 

FDA is requesting OMB approval 

under the PRA (44 U.S.C. 3507) for the 

reporting and recordkeeping 

requirements contained in the guidance 

for industry entitled ‘‘Continuous 

Marketing Applications (CMA): Pilot 

2—Scientific Feedback and Interactions 

During Development of Fast Track 

Products Under PDUFA.’’ This guidance 

discusses how the agency will 

implement a pilot program for frequent 

scientific feedback and interactions 

between FDA and applicants during the 

investigational phase of the 

development of certain Fast Track drug 

and biological products. Applicants are 

asked to apply to participate in the Pilot 

2 program. 

In conjunction with the June 2002 

reauthorization of the Prescription Drug 

User Fee Act of 1992 (PDUFA), FDA 

agreed to meet specific performance 

goals (PDUFA Goals). The PDUFA Goals 

include two pilot programs to explore 

the CMA concept. The CMA concept 

builds on the current practice of 

interaction between FDA and applicants 

during drug development and 

application review and proposes 

opportunities for improvement. Under 

the CMA pilot program, Pilot 2, 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 participate in the program. 

Pilot 2 is an exploratory program that 

allows FDA to evaluate the impact of 

frequent scientific feedback and 

interactions with applicants during the 

investigational new drug application 

(IND) phase. Under the pilot program, a 

maximum of one Fast Track product per 

review division in FDA’s Center for 

Drug Evaluation and Research (CDER) 

and Center for Biologics Evaluation and 

Research (CBER) is selected to 

participate. This guidance provides 

information regarding the selection of 

participant applications for Pilot 2, the 

formation of agreements between FDA 

and applicants on the IND 

communication process, and other 

procedural aspects of Pilot 2. FDA began 

accepting applications for participation 

in Pilot 2 on October 1, 2003. 

The guidance describes one collection 

of information: Applicants who would 

like to participate in Pilot 2 must submit 

an application (Pilot 2 application) 

containing certain information outlined 

in the guidance. The purpose of the 

Pilot 2 application is for the applicants 

to describe how their designated Fast 

Track product would benefit from 

enhanced communications between 

FDA and the applicant during the 

product development process. 

FDA’s regulation at § 312.23 (21 CFR 

312.23) states that information provided 

to the agency as part of an IND must be 

submitted in triplicate and with an 

appropriate cover form. Form FDA 1571 

must accompany submissions under 

INDs. 21 CFR part 312 and FDA Form 

1571 have a valid OMB control number: 

OMB control number 0910–0014, which 

expires May 31, 2009. 

In the guidance document, CDER and 

CBER ask that a Pilot 2 application be 

submitted as an amendment to the 

application for the underlying product 

under the requirements of § 312.23; 

therefore, Pilot 2 applications should be 

submitted to the agency in triplicate 

with Form FDA 1571. The agency 

recommends that a Pilot 2 application 

be submitted in this manner for two 

reasons: (1) To ensure that each Pilot 2 

application is kept in the administrative 

file with the entire underlying 

application and (2) to ensure that 

pertinent information about the Pilot 2 

application is entered into the 

appropriate tracking databases. Use of 

the information in the agency’s tracking 

databases enables the agency to monitor 

progress on activities. 

Under the guidance, the agency asks 

applicants to include the following 

information in the Pilot 2 application: 

• Cover letter prominently labeled 

‘‘Pilot 2 application’’; 

• IND number; 

• Date of Fast Track designation; 

• Date of the end-of-phase 1 meeting, 

or equivalent meeting and summary of 

the outcome; 

• A timeline of milestones from the 

drug or biological product development 

program, including projected date of 

new drug application (NDA)/biologics 

license application submissions; 

• Overview of the proposed product 

development program for a specified 

disease and indication(s), providing 

information about each of the review 

disciplines (e.g., chemistry/ 

manufacturing/controls, pharmacology/ 

toxicology, clinical, clinical 

pharmacology and biopharmaceutics); 

• Rationale for interest in 

participating in Pilot 2, specifying the 

ways in which development of the 

subject drug or biological product 

would be improved by frequent 

scientific feedback and interactions with 

FDA and the potential for such 

communication to benefit public health 

by improving the efficiency of the 

product development program; and 

• Draft agreement for proposed 

feedback and interactions with FDA. 

This information is used by the 

agency to determine which Fast Track 

products are eligible for participation in 

Pilot 2. Participation in this pilot 

program is voluntary. 

Based on the number of Pilot 2 

applications submitted to CDER and 

CBER during fiscal year 2004 and 2005, 

we estimate that the number of 

applications received annually for Pilot 

2 is 7 for products regulated by CDER 


pwalker on PROD1PC71 with NOTICES
28496 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 

and 1 for products regulated by CBER. 

FDA anticipates that approximately 7 

applicants (respondents) will submit 

these Pilot 2 applications annually to 

CDER and approximately 1 applicant 

(respondent) will submit these Pilot 2 

applications annually to CBER. The 

hours per response, which is the 

estimated number of hours that a 

respondent would spend preparing the 

information to be submitted in a Pilot 2 

application in accordance with the 

guidance, is estimated to be 

approximately 80 hours. Based on 

FDA’s experience, we expect it will take 

respondents this amount of time to 

obtain and draft the information to be 

submitted with a Pilot 2 application. 

Therefore, the agency estimates that 

applicants use approximately 640 hours 

annually to submit the Pilot 2 

applications. 

In the Federal Register of July 24, 

2006 (71 FR 41819), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Pilot 2 Application No. of 

Respondents 

No. of 

Responsesper Response Total Responses Hours per 

Response Total Hours 

CDER 7 1 7 80 560 

CBER 1 1 1 80 80 

Total 640 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: May 15, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9709 Filed 5–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007E–0066] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; NOXAFIL 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

NOXAFIL and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions 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. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–007), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the drug product. Although only a 

portion of a regulatory review period 

may count toward the actual amount of 

extension that the Director of Patents 

and Trademarks may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product NOXAFIL 

(posaconazole). NOXAFIL is indicated 

for prophylaxis of invasive Aspergillus 

and Candida infections in patients, 13 

years of age and older, who are at high 

risk of developing these infections due 

to being severely immunocompromised, 

such as hematopoietic stem cell 

transplant recipients with Graft versus 

Host Disease or those with hematologic 

malignancies with prolonged 

neutropenia from chemotherapy. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

NOXAFIL (U.S. Patent No. 5,661,151) 

from Schering Corp., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated March 12, 2007, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of NOXAFIL 

represented the first permitted 

commercial marketing or use of the 

product. Shortly thereafter, the Patent 

and Trademark Office requested that 

FDA determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

NOXAFIL is 3,650 days. Of this time, 

3,382 days occurred during the testing 

phase of the regulatory review period, 

while 268 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: September 19, 

1996. The applicant claims November 6, 

1996, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was September 19, 

1996, which was 30 days after FDA 

receipt of the first IND. 


pwalker on PROD1PC71 with NOTICES