Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79379 

completely. Second, as initial testing, it 

will allow FDA to assess the potential 

effectiveness of messages and materials 

in reaching and successfully 

communicating with their intended 

audiences. Testing messages with a 

sample of the target audience will allow 

FDA to refine messages while still in the 

developmental stage. Respondents will 

be asked to give their reaction to the 

messages in either individual or group 

settings. Third, as evaluative research, it 

will allow FDA to ascertain the 

effectiveness of the messages and the 

distribution method of these messages 

in achieving the objectives of the 

message campaign. Evaluation of 

campaigns is a vital link in continuous 

improvement of communications at 

FDA. 

In the Federal Register of August 19, 

2010 (75 FR 51271), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received comments 

from two individuals and one trade 

association. FDA acknowledges one 

request for additional details on the 

necessity and purpose of the 

information to be collected, but notes 

that comments were invited on FDA’s 

request for a generic clearance related to 

the formative testing of communications 

about veterinary products and products 

for animals. Under this generic 

clearance, details of individual studies 

(research questions, target audiences, 

methodologies, and consultants) will be 

tailored to specific communicationsrelated questions. For each study FDA 

requests under this clearance, FDA will 

provide OMB with these details on the 

information collection. The 

communication development process 

will inform the purpose of the data 

collection and the means by which the 

data will be collected. For very early 

message development, qualitative 

research such as in-depth interviews or 

focus groups will be appropriate. At 

later communication development 

stages, more quantitative data collection 

would be more useful. FDA plans to use 

the data collected under this generic 

clearance to inform its communications 

campaigns. The data will not be used for 

the purposes of making policy or 

regulatory decisions. 

Audience targets are also informed by 

the specific research question. 

Nonetheless, FDA provided more 

information by specifying some of the 

groups more likely to be targeted in 

tasks under this generic clearance, 

including: Consumers, pet owners, large 

animal producers, veterinarians, animal 

distributors, pet shop owners, 

stockyards staff and owners, abattoir 

owners or staff, grocery meat 

purchasers, agricultural extension 

agents, and professors of food science 

and related fields. 

Furthermore, comments related to 

ways to enhance the data collection and 

to assess FDA’s estimate of burden 

indicated that FDA should not limit 

itself to in-house expertise. FDA 

acknowledges that assistance may be 

requested from experts in other 

Government agencies. Depending on the 

specific research question to be 

addressed, FDA may consult experts in 

the United States Department of 

Agriculture and the United States 

Environmental Protection Agency. 

FDA received a comment relating to 

the cruelty and sadism of animal testing. 

In response to this comment, FDA notes 

that its notice was for public comment 

on data collection related to 

communication studies. No animal 

testing is involved. 

FDA received a comment that made a 

series of complaints against the Agency 

unrelated to its notice for public 

comment. Accordingly, those comments 

are not addressed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 U.S.C. 393(d)(2)(D) No. of 

respondents 

Annual frequency 

per response 

Total annual 

responses 

Hours per 

response 

Total 

hours 

Individual in-depth interviews ............................................ 360 1 360 .75 270 

General public focus group interviews ............................. 288 1 288 1.50 432 

Intercept interviews: Central location ................................ 200 1 200 .25 50 

Intercept interviews: Telephone 2 ...................................... 2,000 1 2,000 .08 160 

Self-administered surveys ................................................. 2,400 1 2,400 .25 600 

Gatekeeper reviews .......................................................... 300 1 300 .50 150 

Omnibus surveys .............................................................. 1,200 1 1,200 .17 204 

Total (general public) ........................................................ ............................ ............................ .............................. ............................ 1,866 

Veterinarian/scientific expert focus group interviews ....... 288 1 288 1.50 432 

Total (overall) ............................................................. ............................ ............................ .............................. ............................ 2,298 

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

2These are brief interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1–800 

number. 

Dated: December 7, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31891 Filed 12–17–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Defense Advanced Research Projects 

Agency and Food and Drug 

Administration Expanding In Vivo 

Biomarker Detection Devices 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing the following 

public workshop cosponsored with the 

Defense Advanced Research Projects 

Agency (DARPA): Expanding In Vivo 

Biomarker Detection Devices Workshop. 

The DARPA Defense Sciences Office 

and the FDA Center for Devices and 

Radiological Health (CDRH) are hosting 

a workshop to discuss current state-ofthe-art and innovative research 

opportunities in the area of in vivo 

analytical devices capable of measuring 

biomarkers that characterize normal 

biological processes, pathologic 


jlentini on DSKJ8SOYB1PROD with NOTICES
79380 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 

processes, and pharmacologic 

responses. In particular, this workshop 

will focus on the technical challenges 

for developing implanted or 

continuously applied devices capable of 

measuring and monitoring clinically 

relevant molecular biomarkers (small 

molecules, proteins, peptides, and 

nucleic acids) to alert the user of the 

need for clinical attention and/or to 

inform the clinician with regard to 

appropriate action. 

Date and Time: The workshop will be 

held on February 9, 2011, from 7:30 a.m. 

to 5 p.m. 

Location: The workshop will be held 

at the Executive Conference Center at 

Liberty Center, 4075 Wilson Blvd., suite 

350, Arlington, VA 22203. 

Contact: Jonathan Sackner-Bernstein, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, rm. 

5410, Silver Spring, MD 20903, 301– 

796–5420, e-mail: jonathan.sacknerbernstein@fda.hhs.gov; or Daniel 

Wattendorf, Defense Advanced Research 

Projects Agency, 3701 North Fairfax Dr., 

Arlington, VA 22203, 703–526–6630. 

Administrative questions about the 

workshop should be directed to the 

attention of Ms. Jenifer Schimmenti 

(jschimmenti@sainc.com). 

Registration and Requests for 

Presentations: Registration logistics will 

be managed by DARPA according to 

instructions posted on their Web site at 

http://www.sa-meetings.com/ 

DARPA_FDA_Workshop (login: 

DARPAFDA, password: arlington), 

including instructions for registration 

and presentation of previous or 

potential research and development 

capabilities consistent with the 

workshop goals in order to facilitate 

discussions. The deadline to submit 

abstracts and requests for poster 

presentations is listed on the DARPA 

Web site. After the deadline posted, no 

submissions will be considered. 

If you need special accommodations 

due to a disability, please contact Jenifer 

Schimmenti (see Contact) at least 7 days 

in advance. 

Transcripts: There will not be a 

transcription of this workshop. 

SUPPLEMENTARY INFORMATION: 

Currently available glucose 

monitoring systems provide the most 

developed approach to continuous 

monitoring of a biomarker in real-time. 

Despite FDA approval for human use 

and extensive research and 

development, these monitoring systems 

exhibit several important limitations 

including accuracy/precision, 

durability, adaptability, and reliability. 

For example, many of these 

technologies are limited to detecting one 

biomarker (glucose) in real-time and the 

approach cannot be used for the 

detection of other classes of biomarkers 

(e.g., nucleic acids), nor do they have 

the capabilities for being multiplexed. 

Additionally, these technologies also 

require frequent secondary testing of 

blood glucose levels to assure the 

performance and accuracy of the device. 

Such technical challenges limit the 

ability to conveniently monitor health 

status in real-time settings outside of the 

patient-physician encounter. These 

challenges are not isolated to 

implantable/applied technologies. 

Available in vitro tools are primarily 

developed for intermittent 

measurements, typically within a 

clinical environment, and do not 

account for biologic dynamics or 

responses to environmental stimuli. 

With accelerating advances in 

genomics, epigenomics, transcriptomics, 

proteomics, and microbiomics, 

innumerable biomarkers could be 

informative for the health/disease of 

individuals and/or populations, 

particularly when considering potential 

exposure to allergens, infections, and 

toxins. Owing to the typical paradigm 

for development of diagnostic devices, 

these next generation class of 

biomarkers that function either as a 

surrogate endpoint for efficacy or an 

adverse response do not have their 

clinical utility qualified in the realworld setting. Without a device to 

accurately measure predictive 

biomarkers either continuously or at an 

acceptable interval, clinical utility may 

be difficult to establish and translation 

to accepted screening or diagnostic 

testing may be impaired. Qualification 

of biomarkers that inform an individual 

to seek medical attention or guide a 

medical provider toward an 

intervention or clinical decision, within 

the context of an implanted/applied 

technology, is a priority. 

DARPA and CDRH are seeking to 

understand challenges and develop 

technological advancements necessary 

to enable in vivo medical devices for 

biomarker detection. While glucose is a 

critical biomarker, workshop interest 

will focus broadly on technologies for 

detection of next-generation biomarkers 

including chemical biomarkers, 

proteins, peptides, and nucleic acids. 

The workshop will address the 

challenges for developing in vivo 

devices to clinically validate biomarkers 

for disease screening, surveillance, 

prediction of therapeutic response, or 

prognosis, as well as the potential for 

using an in vivo approach to measure 

biomarkers for safety and effectiveness 

of a therapy (metabolites, toxicity, or 

surrogate endpoints) as part of a realtime Phase 4 postmarketing 

surveillance. 

The workshop will not focus on the 

discovery or identification of relevant 

biomarkers or potential surrogates. 

Instead, the workshop will focus on 

critical topic areas and specific 

technical challenges related to the 

development of in vivo technologies 

capable of biomarker detection. 

We encourage you to address the 

following specific technical challenges 

related to development of in vivo 

devices: 

• Novel materials: Materials and 

chemistries that can be safely applied 

for continuous in vivo detection of 

biomarkers, and do not induce/ 

stimulate a biological response (e.g., 

inflammation). 

• Device design for analytical 

validation: Methods for maximizing and 

verifying accuracy, sensitivity, 

specificity, reproducibility, and 

reliability of in vivo biomarker detection 

methods. 

• Minimal invasiveness: Device 

delivery methods and device size 

reduction, to include issues related to 

on-board versus external power, 

communication, and processing. 

• Maximum duration: Operational 

lifetime of the implanted device to 

include overcoming bio-fouling, 

enhanced biocompatibility, and 

continuous versus periodic 

measurements. 

• Capacity to measure multiple 

biomarkers simultaneously. 

• Capacity to be rapidly adapted to 

measure an emerging biomarker of 

concern. 

• Potential for using an in vivo 

approach to clinically validate 

biomarkers for disease screening, 

surveillance, prediction of therapeutic 

response, or prognosis. 

Ideally, these challenges are within 

the context of the following, as 

summarized in the Institute of Medicine 

(IOM) Evaluation of Biomarker and 

Surrogate Endpoints in Chronic Disease 

2010 Consensus Report (http:// 

books.nap.edu/ 

openbook.php?record_id=12869): 

1. Analytical validation to assure 

biomarker tests are reliable, 

reproducible, and adequately sensitive 

and specific. 

2. Qualification to assure the 

measurement methods can be correlated 

to a clinical outcome of concern. 

3. Utilization analysis to determine 

that the biomarker used to develop the 

technology is appropriate. 

The goals of this workshop are to 

define the current state-of-the-art and 

innovative research opportunities and 

challenges in developing such devices. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79381 

Participants are asked to submit an 

abstract of no more than 250 words to 

explain their research efforts and how 

they specifically pertain to the 

objectives of the Expanding In Vivo 

Biomarker Detection Devices Workshop. 

A workshop representative will contact 

participants after abstract submission. 

Dated: December 14, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–31811 Filed 12–17–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0030] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; FOLOTYN 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

FOLOTYN 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 electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 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 drug 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 FOLOTYN 

(pralatrexate). FOLOTYN is indicated 

for the treatment of patients with 

relapsed or refractory peripheral T-cell 

lymphoma. Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for FOLOTYN (U.S. Patent 

No. 6,028,071) from Southern Research 

Institute, Sloan-Kettering Institute for 

Cancer Research, and SRI International, 

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 3, 2010, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of FOLOTYN represented the 

first permitted commercial marketing or 

use of the product. 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 

FOLOTYN is 4,591 days. Of this time, 

4,406 days occurred during the testing 

phase of the regulatory review period, 

while 185 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 FD&C Act) (21 

U.S.C. 355(i)) became effective: March 2, 

1997. The applicant claims January 31, 

1997, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was March 2, 1997, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: March 24, 2009. 

The applicant claims March 23, 2009, as 

the date the new drug application 

(NDA) for Folotyn (NDA 22–468) was 

initially submitted. However, FDA 

records indicate that NDA 22–468 was 

submitted on March 24, 2009. 

3. The date the application was 

approved: September 24, 2009. FDA has 

verified the applicant’s claim that NDA 

22–468 was approved on September 24, 

2009. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,826 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by February 18, 

2011. Furthermore, any interested 

person may petition FDA for a 

determination regarding whether the 

applicant for extension acted with due 

diligence during the regulatory review 

period by June 20, 2011. To meet its 

burden, the petition must contain 

sufficient facts to merit an FDA 

investigation. (See H. Rept. 857, part 1, 

98th Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

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

through Friday. 


jlentini on DSKJ8SOYB1PROD with NOTICES