29152 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices

entities. Reclassification of the device

from class III to class II will relieve

manufacturers of the cost of complying

with the premarket approval

requirements in section 515 of the act.

Because reclassification will reduce

regulatory costs with respect to this

device, it will impose no significant

economic impact on any small entities,

and it may permit small potential

competitors to enter the marketplace by

lowering their costs. The agency

therefore certifies that this

reclassification action, if finalized, will

not have a significant economic impact

on a substantial number of small

entities. In addition, this reclassification

action will not impose costs of $100

million or more on either the private

sector or State, local, and tribal

governments in the aggregate, and

therefore a summary statement of

analysis under section 202(a) of the

Unfunded Mandates Reform Act of 1995

is not required.

XIII. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

document by August 13, 2001. Two

copies of any comment are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

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

through Friday.

Dated: May 17, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13302 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Science Advisory Board to the

National Center for Toxicological

Research; 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: Science

Advisory Board to the National Center

for Toxicological Research (NCTR).

General Function of the Committee:

The board advises the Director, NCTR,

in establishing, implementing, and

evaluating the research programs that

assist the Commissioner of Food and

Drugs (the Commissioner) in fulfilling

regulatory responsibilities. The board

provides an extra-agency review in

ensuring that the research programs at

NCTR are scientifically sound and

pertinent.

Date and Time: The meeting will be

held on June 11, 2001, 1 p.m. to 5:30

p.m., and June 12, 2001, 8:30 a.m. to 1

p.m.

Location: NCTR, Bldg. #12,

Conference Center, Jefferson, AR.

Contact: Leonard M. Schechtman,

NCTR (HFT–10), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6696, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12559. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The board will be presented

with progress reports on the

implementation of recommendations

made by the board at its last meeting on

NCTR’s research programs in endocrine

disrupter knowledge base and

microbiology. The NCTR director will

provide a center update and a

discussion of future research directions.

A proposal will be made to the board

that it consider establishing a

subcommittee on scientific

opportunities to improve regulatory

science through collaboration with

external stakeholders. A report will be

provided to the board on the activities

of an existing subcommittee with a

similar focus (Advisory Committee for

Pharmaceutical Science, Nonclinical

Studies Subcommittee) NCTR division

directors will discuss the

accomplishments and future directions

for their divisions.

Procedure: On June 11, 2001, from 1

p.m. to 5:30 p.m., and June 12, 2001,

from 8:30 a.m. to 12 noon, 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 May 18, 2001. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 noon on June 12, 2001.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before May 18, 2001,

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

June 12, 2001, from 12 noon to 1 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)). This portion of the meeting

will be closed to permit discussion of

information concerning individuals

associated with the research programs at

NCTR.

The Commissioner approves the

scheduling of meetings at locations

outside the Washington, DC area on the

basis of the criteria of 21 CFR 14.22 of

FDA’s regulations relating to public

advisory committees.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 22, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–13378 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection: Comment

Request; a Study of Motivations and

Deterrents to Blood Donation in the

United States

SUMMARY: In compliance with the

requirement of section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

National Heart, Lung, and Blood

Institute (NHLBI), the National

Institutes of Health (NIH), will publish

periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

Proposed Collection

Title: A Study of Motivations and

Deterrents to Blood Donation in the

United States. Type of Information

Collection Request: NEW. Need and Use

of Information Collection: There are

serious blood shortages in the U.S. and

the situation is predicted to worsen

unless corrective measures are initiated.

Through a randomized, anonymous

mail survey of individuals who have

donated blood at one of the five blood

centers participating in the NHLBI

Retrovirus Donor Study (REDS), this

study will examine the personal, or

Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices 29153

intrinsic reasons for choosing to donate

blood, as well as external reasons for

choosing to donate blood. Donors who

do not initially respond to the mail

survey will be given the opportunity to

complete the survey on a secured

website. Comparisons will be made

between one-time donors and repeat

donors will be premise that repeat

donors may have a stronger altruistic

impetus for donating than donors who

donate less frequently. Donors will be

asked about the donation experience,

the context in which he/she first

donated blood, and questions

addressing accessibility to donate. Using

the Self-Report Altruism Scale,

respondents will rate themselves based

on other personal behaviors that are

considered to exhibit social

responsibility and/or altruism.

Additionally, the study will examine

possible barriers to donation, such as

inconvenience, discomfort, and

confidentiality, among donors who have

not donated recently. With the majority

of the blood supply coming from

committed, repeat donors, information

regarding why an individual decides to

donate, and more importantly, what

motivates them to come back, will

provide valuable insight on possible

strategies to encourage increased

donation frequency among the current

blood donor population. It is also

important to gain perspective on why

only 50% of first time donors return to

donate again. Without successful

recruitment of new regular donors it is

impossible to sustain the blood supply

and availability. Assessment of possible

barriers to donation will provide areas

for focusing improvement in the blood

donation process. Blood availability

continues to be one of the most serious

problems facing the healthcare industry

and was recently compounded by new

Food and Drug Administration

regulations regarding deferring donors

who had traveled to or lived in the

United Kingdom for a cumulative

period of 6 months between 1980 and

1996. Data from this survey will provide

a valuable perspective for devising

strategies to increase blood donation the

U.S. These data will be invaluable to

NHLBI, FDA, and other government

agencies in helping formulate policy for

ensuring Americans that safe blood is

available when needed. Frequency of

Response: Once. Affected Public:

Individuals. Type of Respondents: Adult

Blood Donors. The annual reporting

burden is as follows: Estimated Number

of Respondents: 30,000; Estimated

Number of Respondents per

Respondent: 1; Average Burden Hours

Per Response: 0.25; and Estimated Total

Annual Burden Hours Requested: 7,500.

The annualized cost to respondents is

estimated at: $112,500 (based on $15 per

hour). There are no Capital Costs to

report. There are no Operating or

Maintenance Costs to report.

Type of respondents

Estimated number of respondents

Estimated number of respondents per respondent

Average burden

hours per response

Estimated total

annual burden

hours requested

Adult Blood Donors .......................................................................... 30,000 1 0.25 7,500

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

should address 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 approprated automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

Comments Due Date

Comments regarding this information

collection are best assured of having

their full effect if received on or before

July 30, 2001.

FOR FURTHER INFORMATION CONTRACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact Dr. George J. Nemo,

Group Leader, Transfusion Medicine,

Scientific Research Group, Division of

Blood Diseases and Resources, NHLBI,

NIH, Two Rockledge Center, Suite

10042, 6701 Rockledge Drive, MSC

7950, Bethesda, MD 20892-7950, or call

(301) 435-0075, or e-mail your request

to: nemog@nih.gov.

Dated: May 17, 2001.

Donald Christoferson,

Executive Officer, NHLBI.

[FR Doc. 01–13344 Filed 5–25–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by agencies 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.

Ocular Therapeutic Agent Delivery

Devices And Methods

Michael R. Robinson (NEI), Karl G.

Csaky (NEI), Peng Yuan (NEI),

Cynthia Sung (EM), Robert B.

Nussenblatt (NEI), Janine A. Smith

(NEI)

Serial No. 09/808,149, filed Mar. 15,

2001

Licensing Contact: Dale Berkley; 301/

496–7735 ext. 223; e-mail:

berkleyd@od.nih.gov

The invention is directed to ocular

implant devices for the delivery of

therapeutic agents to the eye in a

controlled and sustained manner.

Implants suitable for either

subconjunctival or intravitreal

placement are the subject of the

invention. These implants permit