Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Notices 52399 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total 1,082 

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

The following burden estimates are 

based on FDA’s experience with 

voluntary recalls under 21 CFR part 7. 

FDA expects no more than two 

mandatory recalls per year, as most 

recalls are done voluntarily. 

Section 810.10(d)—FDA estimates 

that it will take approximately 8 hours 

for the person named in a cease 

distribution and notification order to 

gather and submit the information 

required by this section. The total 

estimated annual burden is 16 hours. 

Section 810.11(a)—Based on 

experience in similar situations, FDA 

expects that there will be only one 

request for a regulatory hearing per year 

and that it will take approximately 8 

hours to prepare this request. 

Section 810.12(a) and (b)—Based on 

experience in similar situations, FDA 

expects that there will be only one 

written request for a review of a cease 

distribution and notification order per 

year and that it will take approximately 

8 hours to prepare this request. 

Section 810.14—Based upon its 

experience with voluntary recalls, FDA 

estimates that it will take approximately 

16 hours to develop a strategy for 

complying with the order. 

Section 810.15(a) through (d)—Based 

upon its experience with voluntary 

recalls, FDA estimates that it will take 

approximately 16 hours to notify each 

health professional, user facility, or 

individual of the order. 

Section 810.15(e)—Based upon its 

experience with voluntary recalls, FDA 

estimates that there will be 

approximately 5 consignees per recall 

(10 per year) who will be required to 

notify their consignees of the order. 

FDA estimates that it will take them 

about 1 hour to do so. 

Section 810.16—FDA estimates that it 

would take no more than 40 hours to 

assemble and prepare a written status 

report required by a recall. The status 

reports are prepared by manufacturers 6 

to 12 times each year. Therefore, each 

manufacturer would spend no more 

than 480 hours each year preparing 

status reports. If there were two FDA 

invoked recalls each year, the total 

burden hours estimated would be 960 

hours each year. 

Section 810.17—Based on experience 

with similar procedures, FDA estimates 

that it would take 8 hours to draft a 

written request for termination of a 

cease distribution and notification or 

mandatory recall order. 

Dated: August 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17499 Filed 9–1–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Blood Products Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Blood Products 

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 September 29, 2005, from 8 a.m. 

to 5 p.m. 

Location: Food and Drug 

Administration, conference room 1066, 

5630 Fishers Lane, Rockville, MD. 

Contact Person: Donald W. Jehn or 

Pearline K. Muckelvene, Center for 

Biologics Evaluation and Research 

(HFM–71), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852, 301–827–0314, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014519516. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On September 29, 2005, the 

committee will discuss new drug 

application (NDA) 21–882 proposed 

trade name EXJADE (deferasirox) 

Tablets for Oral Suspension, Novartis 

Pharmaceutical Corp., proposed for the 

indication of the treatment of chronic 

iron overload due to blood transfusions 

(transfusional hemosiderosis). 

Following this discussion, the 

committee will hear an overview of the 

research programs in the Laboratory of 

Hemostasis and the Laboratory of 

Plasma Derivatives, Division of 

Hematology, Office of Blood Research 

and Review, Center for Biologics 

Evaluation and Research (CBER), and in 

closed session will discuss the report 

from the laboratory site visit of February 

25, 2005. 

Procedure: On September 29, 2005, 

from 8 a.m. to 4:15 p.m., the meeting is 

open to the public. 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 by September 22, 2005. Oral 

presentations from the public will be 

scheduled between approximately 11:15 

a.m. and 12:15 p.m. Time allotted for 

each presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before September 22, 2005, 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. 

Closed Committee Deliberations: On 

September 29, 2005, from 

approximately 4:15 p.m. to 5 p.m., the 

meeting will be closed to permit 

discussion where disclosure would 

constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The committee will discuss 

a review of internal research programs 

in the Division of Hematology, Office of 

Blood Research and Review, Center for 

Biologics Evaluation and Research. 

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 Donald Jehn 

or Pearline K. Muckelvene at least 7 

days in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

52400 Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Notices 

Dated: August 26, 2005. 

Scott Gottlieb, 

Deputy Commissioner for Policy. 

[FR Doc. 05–17470 Filed 9–1–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection: Comment 

Request; Extension of OMB No. 0925–

0417/exp. 08/31/05, Responsibility of 

Applicants for Promoting Objectivity in 

Research for Which Public Health 

Service Funding Is Sought and 

Responsible Prospective 

Contractors—42 CFR Part 50, 

Subpart F 

Summary: In compliance with the 

requirement of Section 3507(a)(1)(D) of 

the Paperwork Reduction Act of 1995, 

the Office of the Director (OD), Office of 

Extramural Research (OER), the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. Proposed 

information collection was previously 

published in the Federal Register on 

May 12, 2005, Volume 70, No. 91, page 

25095 and allowed 60 days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: 

Responsibility of Applicants for 

Promoting Objectivity in Research for 

Which Public Health Service Funding Is 

Sought and Responsible Prospective 

Contractors—42 CFR Part 50, Subpart F; 

Type of Information Collection Request: 

Extension, OMB 0925–0417, Expiration 

Date 8/31/05. Need and Use of 

Information Collection: This is a request 

for OMB approval for the information 

collection and recordkeeping 

requirements contained in the final rule 

42 CFR Part 50 Subpart F and 

Responsible Contractors: 45 CFR Part 

94. Frequency of response: On occasion. 

Affected Public: Individuals or 

households; business or other for-profit; 

not-for-profit institutions; and State, 

Local or Tribal Government. Type of 

Respondents: Any public or private 

entity or organization. The annual 

reporting burden is as follows: 

Estimated Number of Respondents: 

42,800; Estimated Number of Responses 

per Respondent: 1.60; Average Burden 

Hours Per Response: 3.40; and 

Estimated Total Annual Burden Hours 

Request: 232,000. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) the accuracy of the agency’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 those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time should be directed to the Office of 

Management and Budget, Office of 

Regulatory Affairs, New Executive 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIR. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Ms. 

Diane Dean, Division of Grants Policy, 

Office of Policy for Extramural Research 

Administration, NIH, Rockledge 1 

Building, Room 3525, 6705 Rockledge 

Drive, Bethesda, MD 20892–7974, or 

call non-toll-free number 301–435–

0930, or E-mail your request, including 

your address to: hahnm@od.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: August 25, 2005. 

Charles Mackay, 

Chief, Project Clearance Branch, OPERA, 

OER, National Institutes of Health. 

[FR Doc. 05–17458 Filed 9–1–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing: Selected 

Technologies From the NIH Cancer 

Therapeutics Portfolio 

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 

contacting George G. Pipia, Ph.D., 

Technology Licensing Specialist, Office 

of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852; telephone: 301/435–

5560; fax: 301/402–0220; e-mail: 

pipiag@mail.nih.gov. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Antitumor Macrocyclic Lactones 

Michael R. Boyd (NCI). 

U.S. Patent No. 6,353,019 issued 05 Mar 

2002 (HHS Reference No. E–244–

1997/0–US–07) and related foreign 

patent applications. 

Vacuolar-Type (H+)-ATPase-Inhibiting 

Compounds and Uses Thereof 

Michael R. Boyd (NCI). 

U.S. Patent Application No. 09/914,708 

filed 31 Aug 2001 (HHS Reference No. 

E–244–1997/3–US–06) and related 

foreign patent applications. 

This technology covers a broad 

composition of matter which includes 

the salicylihalamides, lobatamides, and 

numerous other structurally related 

small molecules which have been 

shown to inhibit mammalian vacuolar 

ATPase at low nanomolar 

concentrations. The compounds are also 

potent inhibitors of cancer cell growth, 

with particular specificity for 

melanoma, osteosarcoma and selected 

lung, colon and CNS tumor cell lines. 

Experimental tumor and 

pharmacokinetic studies are underway