67984 Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and 

(4) ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry on 

Pharmacogenomic Data Submissions 

(OMB Control Number 0910–0557— 

Extension) 

The guidance provides 

recommendations to sponsors 

submitting or holding INDs, NDAs, or 

BLAs on what pharmacogenomic data 

should be submitted to the agency 

during the drug development process. 

Sponsors holding and applicants 

submitting INDs, NDAs, or BLAs are 

subject to FDA requirements for 

submitting to the agency data relevant to 

drug safety and efficacy (§§ 312.22, 

312.23, 312.31, 312.33, 314.50, 314.81, 

601.2, and 601.12). 

The guidance interprets FDA 

regulations for IND, NDA, or BLA 

submissions, clarifying when the 

regulations require pharmacogenomics 

data to be submitted and when the 

submission of such data is voluntary. 

The pharmacogenomic data submissions 

described in the guidance that are 

required to be submitted to an IND, 

NDA, BLA, or annual report are covered 

by the information collection 

requirements under parts 312, 314, and 

601 (21 CFR parts 312, 314, and 601) 

and are approved by OMB under control 

numbers 0910–0014 (part 312—INDs); 

0910–0001 (part 314—NDAs and annual 

reports); and 0910–0338 (part 601— 

BLAs). 

The guidance distinguishes between 

pharmacogenomic tests that may be 

considered valid biomarkers appropriate 

for regulatory decision-making, and 

other, less well-developed exploratory 

tests. The submission of exploratory 

pharmacogenomic data is not required 

under the regulations, although the 

agency encourages the voluntary 

submission of such data. 

The guidance describes the voluntary 

genomic data submission (VGDS) that 

can be used for such a voluntary 

submission. The guidance does not 

recommend a specific format for the 

VGDS, except that such a voluntary 

submission be designated as a VGDS. 

The data submitted in a VGDS and the 

level of detail should be sufficient for 

FDA to be able to interpret the 

information and independently analyze 

the data, verify results, and explore 

possible genotype-phenotype 

correlations across studies. FDA does 

not want the VGDS to be overly 

burdensome and time-consuming for the 

sponsor. 

FDA has estimated the burden of 

preparing a voluntary submission 

described in the guidance that should be 

designated as a VGDS. Based on FDA’s 

experience with this guidance over the 

past few years, and on FDA’s familiarity 

with sponsors’ interest in submitting 

pharmacogenomic data during the drug 

development process, FDA estimates 

that approximately seven sponsors will 

submit approximately one VGDS and 

that, on average, each VGDS will take 

approximately 50 hours to prepare and 

submit to FDA. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Annual 

frequency 

per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Voluntary Genomic Data Submissions Total ....................... 7 1 7 50 350 

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

Dated: October 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27847 Filed 11–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0381] 

Generic Drug User Fee; Notice of 

Public Meeting; Reopening of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

December 6, 2010, the comment period 

for the notice of public meeting entitled 

Generic Drug User Fee; Public Meeting; 

Request for Comments, published in the 

Federal Register of August 9, 2010 (75 

FR 47820). In that notice, FDA 

announced a public meeting that took 

place on September 17, 2010, to gather 

stakeholder input on the development 

of a generic drug user fee program. FDA 

is reopening the comment period to 

permit public consideration of latereceived comments and to provide an 

opportunity for all interested parties to 

provide information and share views on 

the matter. 

DATES: Submit either electronic or 

written comments by December 6, 2010. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 67985 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit 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: 

Peter C. Beckerman, Office of Policy, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

4238, Silver Spring, MD 20993–0002, 

301–796–4830, Fax: 301–847–3541, Email: peter.beckerman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 9, 

2010 (75 FR 47820), FDA published a 

notice of a public meeting on the 

development of a generic drug user fee 

program. In that notice, FDA posed 

several questions related to a user fee for 

human generic drugs, and sought public 

input on such a program. The Agency 

received submissions and presentations 

from the public meeting, which are now 

posted on FDA’s Web site. Some 

submissions arrived after the formal 

closing of the docket and FDA has 

decided to reopen the docket to permit 

public input on all the submissions. 

Interested persons were originally 

given until October 17, 2010, to 

comment on the development of a 

generic drug user fee program. FDA is 

now reopening the docket to permit 

comment until December 6, 2010. 

II. Request for Comments 

Following publication of the August 

9, 2010, meeting notice and request for 

comment, FDA received a request to 

allow interested persons additional time 

to comment. The requester asserted that 

the time period of 30 days was 

insufficient to respond fully to FDA’s 

specific requests for comments and to 

allow potential respondents to 

thoroughly evaluate and address 

pertinent issues. In light of this request, 

and the arrival of late submitted 

comments, FDA is reopening the 

comment period for an additional 30 

days. 

III. How To Submit Comments 

Regardless of attendance at the public 

meeting, interested persons may submit 

to the Division of Dockets Management 

(see ADDRESSES) either electronic or 

written comments regarding this 

document. It is only necessary to send 

one set of comments. It is no longer 

necessary to send two copies of mailed 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: October 29, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–27824 Filed 11–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

Federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

System for Magnetic Resonance 

Spectroscopy of Brain Tissue for 

Pattern-Based Diagnostics 

Description of Invention: Available for 

licensing and commercial development 

is a system for preprocessing magnetic 

resonance spectroscopy (MRS) data of 

brain tissue for pattern-based 

diagnostics. The MRS preprocessing 

system includes an MRS preprocessing 

module that executes an operation that 

normalizes MRS spectrum data, 

recalibrates and scales the normalized 

MRS spectrum data, and then 

renormalizes the scaled MRS spectrum 

data. The resulting preprocessed MRS 

data is used to assist in identifying 

abnormalities in tissues shown in MRS 

scans. Raw MRS spectrum data and 

scaling the raw MRS spectrum data is 

achieved by a plurality of weighting 

constants to generate a preprocessed 

MRS spectrum data. The method may 

also include providing raw MRS 

spectrum data, recalibrating the raw 

MRS spectrum data, and scaling the 

recalibrated MRS spectrum data by 

using a plurality of weighting constants 

to generate a preprocessed MRS 

spectrum data. 

Applications 

• MRI Imaging. 

• Brain Imaging. 

• Neurology. 

Inventors: Jon G. Wilkes (FDA/NCTR), 

Dan A. Buzatu (FDA/NCTR), Pierre 

Alusta (FDA/NCTR), Bruce A. Pearce 

(FDA/NCTR), Richard Beger (FDA/ 

NCTR), Inessa Im (FDA/NCTR). 

Patent Status: U.S. Provisional 

Application No. 61/261,170 filed 13 

Nov 2009 (HHS Reference No. E–298– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Michael A. 

Shmilovich, Esq.; 301–435–5019; 

shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The FDA National Center for 

Toxicological Research is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize FDA’s magnetic 

resonance spectroscopy technology in 

various imaging and diagnostic 

applications. Please contact Alice Y. 

Welch, PhD at 301–796–8449 or 

alice.welch@fda.hhs.gov for more 

information. 

Cancer-Linked Sequences Encoding the 

A2BP1/FOX1 Gene 

Description of Invention: 

Mesothelioma is a rare type of cancer in 

which malignant cells are found in the 

lining of the chest or abdomen. 

Symptoms are frequently misdiagnosed 

and an accurate diagnosis generally 

does not occur until advanced stages, 

and patients live on average nine to 

thirteen months after an accurate 

diagnosis. To date, there are no effective 

systemic treatments. 

Researchers at the National Cancer 

Institute, NIH, have identified a 

recurrent alteration in the DNA 

sequence for ataxin-2 binding protein 

(A2BP1/FOX1) in human mesothelioma 

and colorectal cancers that is present in 

at least twenty percent (20%) of cancer 

cell lines and primary tumor samples. 

The sequence is not present in normal 

tissue, proving that it has arisen as an 

acquired somatic mutation in cancer. 

Furthermore, additional data suggests a 

possible role for the alteration in 

neurological diseases such as autism, 


jlentini on DSKJ8SOYB1PROD with NOTICES