Federal Register / Vol. 62, No. 248 / Monday, December 29, 1997 / Notices 67643

is estimated using a rate of $10.00 per

hour. The annualized cost to

respondents is estimated at: $23,820.

There are no Capital Costs. There are no

Operating and Maintenance Costs to

report.

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 functions of the agency, including

whether the information shall 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, D.C. 20503, Attention:

Desk Officer for NIH. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact Ms.

Suzanne Anthony, Project Clearance

Liaison, National Heart, Lung, and

Blood Institute, NIH, Building 31, Room

5A10, MSC 2490, 31 Center Drive,

Bethesda, MD 20892–2490 or call nontoll free number (301) 496–9737, or email your request or comments,

including your address, to:

AnthonyS@gwgate.nhlbi.nih.gov.

Comments Due Date

Comments regarding this information

collection are best assured of having

their full effect if received on or before

January 28, 1998.

Dated: December 17, 1997.

Sheila E. Merritt,

Executive Officer, NHLBI.

[FR Doc. 97–33744 Filed 12–24–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Submission for OMB Review;

Comment Request, National Donor

Research and Education Study–II

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. This proposed

information collection was previously

published in Volume 62, Number 86 of

the Federal Register on May 5, 1997

(page 24,492) and allowed 60 days for

public comment. One comment was

received. An individual requested a

summary of the study protocol, which

was provided to them. 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: National Donor Research and

Education Study–II. Type of Information

Collection Request: Reinstatement with

changes to OMB #0925–0383, Expiration

date: 1/31/96. Need and Use of

Information Collection: This study is the

second large anonymous mail survey to

be sent to a random sample of blood

donors at five blood centers

participating in the Retrovirus

Epidemiology Donor Study (REDS). In

addition to the REDS blood centers, this

survey will also be sent to a sample of

donors in selected non-REDS regions

that utilize a variety of donor incentives.

Study results will provide data for

monitoring the safety of the U.S. blood

supply, and will facilitate the

development, evaluation and refinement

of educational, recruitment and

qualification strategies for U.S. blood

donors. The proposed new study will

update and extend the unique findings

obtained in the first blood donor survey

so as to minimize the likelihood that

donors with risk factors for transfusiontransmitted diseases will enter the blood

donor pool. There is a strong likelihood

that, like the first survey effort, the

resulting findings will be directly

applied to blood banking operational

practice. The new survey is specifically

designed to obtain data on the

prevalence and impact of donor

incentives on donor retention and blood

safety. The FDA has identified this as a

priority area for investigation. Other

specific objectives of this survey are to:

(1) Evaluate donor understanding and

acceptance, and the safety impact of

newly-changed laboratory and donor

screening procedures that have been

implemented since the previous donor

survey study (e.g., removal of the

confidential unit exclusion ‘‘CUE’’

process at two REDS sites; additional

questions about Creutzfeldt-jakob and

parasitic diseases; and addition of HIV

p24 antigen testing); (2) Estimate the

efficacy, safety impact and donor

acceptance of new donor screening

procedures that are anticipated to occur

within the next 12–24 months (e.g.,

improved CUE procedures,

implementation of computer-assisted

donor screening); (3) Provide ‘‘pre-’’

(baseline) and ‘‘post-’’ (evaluation)

measures for new donor qualification

procedures expected to occur

operationally at blood centers within

the time period of study including:

deferral for intranasal cocaine use in the

past year; modification of the time

period for sexual risk deferrals from

‘‘since 1977’’ to within the past (12 or

24) months; clarification of wording

regarding sexual contact with ‘‘at-risk’’

individuals; and addition of questions

about donating primarily for the

purpose of receiving the test results for

the AIDS virus; (4) Assess changes in

the prevalence and characteristics of

donors who report donating for

therapeutic reasons (e.g., those with iron

storage disease), and donors who report

donating primarily to receive test results

for the AIDS virus as a result of the

March 1996 implementation of HIV p24

antigen testing; (5) Determine the extent

to which active donors with reactive

tests for anti-HBc and syphilis have

increased levels of behavioral risks that

should have resulted in deferral; (6)

Measure the extent to which

seropositivity for current syphilis

screening tests predicts a recent history

of diagnosed syphilis; (7) Measure blood

donor knowledge of infectious disease

risks and the behavioral factors that

should defer them from donating, to

identify weaknesses in the current

donor educational process, and (8)

Assess the attitudes of donors regarding

establishment of stored frozen

repositories from their donations, use of

these samples for future research testing

designed to improve transfusion safety,

and the adequacy of different levels of
67644 Federal Register / Vol. 62, No. 248 / Monday, December 29, 1997 / Notices

informed consent. Frequency of Response: One-time data collection.

Affected Public: Individuals.

Type of respondents

Estimated

number of

respondents

Estimated

number of

responses

per respondent

Average

burden

hours per

responses

Estimated

total annual

burden

hours requested

Blood Donors .................................................................................................................... 78,000 1 .3333 25,997

The annualized cost to respondents is

estimated at: $259,974 (based on $10 per

hour). There are no Capital Costs to

report. There are no Operating or

Maintenance Costs to report.

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 NIH. To request more

information on the proposed project or

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 Centre, Suite 10042,

6701 Rockledge Drive, MSC 7950,

Bethesda, MD 20892–7950, or call nontoll free number (301) 435–0075 or email your request, including your

address to:

nemog@gwgate.nhlbi.nih.gov.

Comments Due Date

Comments regarding this information

collection are best assured of having

their full effect if received on or before

January 28, 1998.

Dated: December 17, 1997.

Sheila E. Merritt,

Executive Officer, NHLBI.

[FR Doc. 97–33745 Filed 12–24–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Cooperative Research and

Development Agreement (CRADA)

Opportunity and/or Licensing

Opportunity for Materials and Methods

for Protection of Tissue From Ischemic

Damage

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health is seeking CRADA partners and/

or licensees for the further development,

evaluation, and commercialization of

materials and methods for protecting

tissues from cell injury by Ischemia. The

invention claimed in U.S. Patent

Application Serial No. 60/053,843,

‘‘12(S)=HpETE (A 12=Lipoxygenase

Metabolite) Significantly Reduces Cell

Injury,’’ is available for licensing (in

accordance with 35 U.S.C. 207 and 37

CFR Part 404) and/or further

development under one or more

CRADAs in several clinically important

applications as described below in the

SUPPLEMENTARY INFORMATION.

DATES: CRADA proposals should be

received on or before March 30, 1998 for

priority consideration. However,

CRADA proposals submitted thereafter

will be considered until a suitable

CRADA Collaborator is selected.

ADDRESSES: CRADA proposals and

questions should be addressed to Dr.

Jonathan Gottlieb, National Heart, Lung,

and Blood Institute, Technology

Transfer Service Center, 31 Center Drive

MSC 2490, Room 1B32, Bethesda,

Maryland 20892–2490; Telephone: 301/

402–5579; Fax: 301/594–3080; E-mail:

GottlieJ@gwgate.nhlbi.nih.gov.

Questions about the licensing

opportunity should be addressed to

Carol Lavrich, Technology Licensing

Specialist, Office of Technology

Transfer, National Institutes of Health,

6011 Executive Boulevard, Suite 325,

Rockville, Maryland 20852–3804;

Telephone 301/496–7735 ext. 287; Fax

301/402–0220; E-mail: Carol—

Lavrich@nih.gov.

SUPPLEMENTARY INFORMATION: Ischemia

and reperfusion injury are significant

causes of tissue damage in diseases and

conditions such as heart attack, stroke

and in organ transplantation. Recently,

scientists at the National Institute of

Environmental Health Sciences and

Duke University, while investigating the

phenomena of preconditioning,

discovered and developed a highly

effective method for protecting tissues

from cell injury by ischemia by use of

12(S)=HpETE.

Previously developed treatments to

prevent ischemic damage are greatly

limited in their effectiveness. TPA,

routinely used to dissolve blood clots,

thereby allowing greater blood flow,

does not prevent ischemic tissue injury.

Aspirin has been shown to have only a

small protective effect in the

cardiovascular system. However, the

above new method demonstrates a

dramatic protective effect—up to 82%

recovery in initial studies—when

administered during injury, as seen in

animal models. The protective effect of

12(S)-HpETE was discovered during

investigation of the 12-lipoxygenaserelated protective effect of ischemic

preconditioning and, unlike other

agents, 12(S)-HpETE has no known

undesirable side effects.

Uses of such an invention may

include treatment of tissue during

angioplasty and treatment of organs

intended for transplantation to limit the

chance of damage.

This research was published in

Circulation Research 76: 457–467, 1995.

Information about the patent

application and pertinent information

not yet publicly described can be

obtained under a Confidential