75176 Federal Register / Vol. 75, No. 231 / Thursday, December 2, 2010 / Notices 

animal drug user fees and fee waivers 

and reductions. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 31, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.regulations.

gov. Submit written comments on the 

collection of information to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. All comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Johnny Vilela, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7651, Juanmanuel.Vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

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. 

Animal Drug User Fees and Fee 

Waivers and Reductions—(OMB 

Control Number 0910–0540—Extension) 

Enacted on November 18, 2003, the 

Animal Drug User Fee Act (ADUFA) 

(Pub. L. 108–130) amended the Federal 

Food, Drug, and Cosmetic Act and 

requires FDA to assess and collect user 

fees for certain applications, products, 

establishments, and sponsors. It also 

requires the Agency to grant a waiver 

from, or a reduction of those fees in 

certain circumstances. Thus, to 

implement this statutory provision of 

ADUFA, FDA developed a guidance 

entitled ‘‘Guidance for Industry: Animal 

Drug User Fees and Fee Waivers and 

Reductions.’’ It provides guidance on the 

types of fees FDA is authorized to 

collect under ADUFA, and on how to 

request waivers and reductions from 

FDA’s animal drug user fees. The 

guidance also describes the types of fees 

and fee waivers and reductions, the 

information FDA recommends 

respondents submit in support of a 

request for a fee waiver or reduction, 

how respondents may submit such a 

request, and FDA’s process for 

reviewing requests. 

Respondents to this collection of 

information are new animal drug 

sponsors. Requests for waivers or 

reductions may be submitted by a 

person paying any of the animal drug 

user fees assessed—application fees, 

product fees, establishment fees, or 

sponsor fees. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response 

Total 

hours 

740(d)(1)(A) Significant barrier to innovation ...................... 22 1 22 2 44 

740(d)(1)(B) Fees exceed cost ........................................... 0 1 0 2 0 

740(d)(1)(C) Free choice feeds .......................................... 2 1 2 2 4 

740(d)(1)(D) Minor use or minor species ........................... 52 1 52 2 104 

740(d)(1)(E) Small business ............................................... 0 1 0 0 0 

Request for reconsideration of a decision ........................... 5 1 5 2 10 

Request for review—(user fee appeal officer) ..................... 2 1 2 2 4 

Total .............................................................................. ........................ ........................ ........................ ........................ 166 

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

Based on FDA’s database system, 

there are an estimated 250 sponsors of 

products subject to ADUFA. However, 

not all sponsors will have any 

submissions in a given year and some 

may have multiple submissions. The 

total number of waiver requests is based 

on the number of submission types 

received by FDA in fiscal year 2008. 

Dated: November 24, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30264 Filed 12–1–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Gastrointestinal Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 231 / Thursday, December 2, 2010 / Notices 75177 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Gastrointestinal 

Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on January 12, 2011, from 8 a.m to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, Bldg. 31, the 

Great Room, White Oak Conference 

Center (rm. 1503). Information regarding 

special accommodations due to a 

disability, visitor parking and 

transportation may be accessed at: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘White Oak Conference Center 

Parking and Transportation Information 

for FDA Advisory Committee Meetings.’’ 

Please note that visitors to the White 

Oak Campus must have a valid driver’s 

license or other picture ID, and must 

enter through Building 1. 

Contact Person: Kristine T. Khuc, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, e-mail: 

kristine.khuc@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512538. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the Agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On January 12, 2011, the 

committee will discuss the safety and 

efficacy of new drug application (NDA) 

022–486, for Solpura (liprotamase) 

Capsules, by Alnara Pharmaceuticals, 

for the proposed indication (use) in the 

treatment of exocrine pancreatic 

insufficiency due to cystic fibrosis, 

chronic pancreatitis, pancreatectomy 

(surgical removal of all or part of the 

pancreas), or other conditions that may 

impair or limit function of the pancreas. 

The pancreas is an organ involved, in 

part, in the digestion of food through the 

use of specialized proteins called 

enzymes. Exocrine pancreatic 

insufficiency is a decreased ability to 

digest food due to deficient enzyme 

production by the pancreas. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before December 28, 2010. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. to 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before 

December 17, 2010. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by December 20, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Kristine T. 

Khuc at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: November 26, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30274 Filed 12–1–10; 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. 

Novel Compositions and Methods To 

Treat Glioblastoma and Other Cancers 

Description of Technology: There 

remains a significant unmet need for 

therapeutics to treating glioblastoma 

multiforme, a very aggressive type of 

brain tumor. Glioblastoma is difficult to 

treat with conventional surgery, 

chemical, and radiation therapies. With 

approximately 18,000 new glioblastoma 

cases in the U.S. each year, and a 

comparable market in Europe, the global 

market for such products forecast to be 

over $300 million. In light of the high 

unmet need in malignant astrocytoma 

and little in the way of pipeline 

competition, this indication represents a 

potential easy route to market for new 

drugs. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES