31794 Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 

abundant secreted proteins from the 

salivary glands of the sand fly 

Lutzomyia longipalpis, vector of 

Leishmania chagasi. J Exp Biol. 2004 

Oct; 207(Pt 21):3717–3729. [PubMed: 

15371479] 

3. Valenzuela JG, Belkaid Y, Garfield 

MK, Mendez S, Kamhawi S, Rowton ED, 

Sacks DL, Ribeiro JM. Toward a defined 

anti-Leishmania vaccine targeting vector 

antigens: Characterization of a 

protective salivary protein. J Exp Med. 

2001 Aug 6; 194(3):331–342. [PubMed: 

11489952] 

4. Belkaid Y., Valenzuela JG, 

Kamhawi S., Rowton E., Sacks DL, 

Ribeiro JM. Delayed-type 

hypersensitivity to Phlebotomus 

papatasi sand fly bite: An adaptive 

response induced by the fly? Proc Natl 

Acad Sci U S A. 2000 Jun 6; 

97(12):6704–6709. [PubMed: 10841567] 

Patent Status 

• U.S. Patent Application No. 60/ 

422,303 filed October 29, 2002 (HHS 

Ref. No. E–285–2002/0–US–01). 

• PCT Application No. PCT/US2003/ 

03453 filed October 29, 2003 (HHS Ref. 

No E–285–2002/0–PCT–02). 

Application filed in the following 

countries: the USA, Europe, Brazil, 

Japan, Mexico, India and Israel. 

• U.S. Patent No. 7,485,386 issued 

February 3, 2009 (HHS Reference No. E– 

285–2002/0–US–03). 

• European Patent Number No. 

1572968 issued April 22, 2009 (HHS 

Reference No. E–285–2002/0–EP–04). 

• PCT Application No. PCT/US2009/ 

042980 filed May 05, 2009 (HHS 

Reference No. E–189–2008/2–PCT–01). 

• U.S. Patent Application No. 60/ 

421,327 filed September 19, 2002 (HHS 

Ref. No. E–130–2002/0–US–01). 

• PCT Application No. PCT/US03/ 

29833 filed September 18, 2003 (HHS 

Ref. No. E–130–2002/0–PCT–02). 

Application filed in the following 

countries: USA, Europe, Brazil, Japan, 

Mexico, India and Israel. 

Licensing Status: Available for 

licensing. 

Licensing Contact: John Stansberry, 

PhD; 301–435–5236; 

stansbej@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID, OTD is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize ‘‘Vaccines Comprising 

Sand Fly Salivary Proteins for Control of 

Leishmania Infection’’. Please contact 

Dana Hsu at 301–451–3521 for more 

information. 

Dated: May 26, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–13480 Filed 6–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0406] 

Information Sheet Guidance for 

Sponsors, Clinical Investigators, and 

IRBs; Frequently Asked Questions— 

Statement of Investigator (Form FDA 

1572); Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of an information sheet 

guidance entitled, ‘‘Information Sheet 

Guidance for Sponsors, Clinical 

Investigators, and IRBs; Frequently 

Asked Questions—Statement of 

Investigator (Form FDA 1572).’’ This 

guidance is intended to assist sponsors, 

clinical investigators, and institutional 

review boards (IRBs) involved in 

clinical investigations of investigational 

drugs and biologics in completing the 

Statement of Investigator form (Form 

FDA 1572). FDA developed this 

information sheet guidance in response 

to numerous questions from the 

research community regarding Form 

FDA 1572. This information sheet 

guidance provides FDA’s responses to 

the most frequently asked questions. 

DATES: Submit either written or 

electronic comments on agency 

guidances at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information (HFD– 

240), 10903 New Hampshire Ave., 

Silver Spring, MD 20993 or to the Office 

of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the information 

sheet guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Salewski, Division of Scientific 

Investigations, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring MD 20993, 301– 

796–3395. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

an information sheet guidance entitled, 

‘‘Information Sheet Guidance for 

Sponsors, Clinical Investigators, and 

IRBs; Frequently Asked Questions— 

Statement of Investigator (Form FDA 

1572).’’ This guidance is intended to 

assist sponsors, clinical investigators, 

and IRBs involved in clinical 

investigations of investigational drugs 

and biologics in complying with the 

requirement that each investigator 

complete and sign a Form FDA 1572 

before participating in an investigation. 

This guidance describes how to 

complete the Statement of Investigator 

form (Form FDA 1572). 

FDA developed this information sheet 

guidance in response to numerous 

questions from the research community 

regarding the Form FDA 1572. In this 

guidance, we provide answers to 

frequently asked questions concerning 

the purpose of this form, when this form 

needs to be completed and signed by the 

investigator, how to best complete the 

various blocks within the form, and 

when the form might need to be 

updated. In addition, we clarify 

questions related to the use of Form 

FDA 1572 by clinical investigators 

participating in studies conducted 

outside the United States that may or 

may not be under an investigational 

new drug application. 

This information sheet guidance is 

part of the Information Sheet Guidance 

Initiative, announced on February 3, 

2006, in the Federal Register (71 FR 

5861), which describes FDA’s intention 

to update the process for developing, 

issuing, and making available guidances 

intended for IRBs, clinical investigators, 

and sponsors. Known as ‘‘Information 

Sheets,’’ these guidances have provided 

recommendations to IRBs, clinical 

investigators, and sponsors to help them 

fulfill their responsibilities to protect 

human subjects who participate in 

research regulated by the FDA since the 

early 1980s. The Information Sheet 

Guidance Initiative is intended to 

ensure that the Information Sheets are 

consistent with the FDA’s good 

guidance practices (GGPs). As part of 

the initiative, which will be ongoing, 

the agency plans to rescind Information 

Sheets that are obsolete, revise and 

reissue Information Sheet Guidances 

that address current issues, and develop 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 31795 

new Information Sheet Guidances as 

needed. 

In the Federal Register of July 29, 

2008 (73 FR 43940), FDA announced the 

availability of a draft version of the 

guidance entitled, ‘‘Draft Information 

Sheet Guidance for Sponsors, Clinical 

Investigators, and IRBs; Frequently 

Asked Questions—Statement of 

Investigator (Form FDA 1572).’’ The July 

2008 guidance gave interested persons 

an opportunity to submit comments 

through September 29, 2008. All 

comments received during the comment 

period have been carefully reviewed 

and, where appropriate, incorporated in 

the guidance. As a result of the public 

comments and editorial changes, the 

guidance is clearer than the draft 

version. 

This information sheet guidance is 

being issued consistent with FDA’s 

GGPs regulation (21 CFR 10.115). The 

information sheet guidance represents 

the agency’s current thinking on 

completing the Form FDA 1572. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information for 

Form FDA 1572 have been approved 

under OMB Control No. 0910–0014. 

III. Comments 

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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance7

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: May 27, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13420 Filed 6–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review, Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Cell Death 

in Neurodegeneration. 

Date: June 11, 2010. 

Time: 9 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites, 1250 22nd Street, 

NW., Washington, DC 20037. 

Contact Person: Seetha Bhagavan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5194, 

MSC 7846, Bethesda, MD 20892, (301) 237– 

9838, bhagavas@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: May 27, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13412 Filed 6–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel, Pediatric Trials 

Network. 

Date: June 23, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Sathasiva B. Kandasamy, 

PhD, Scientific Review Administrator, 

Division of Scientific Review, National 

Institute of Child Health and Human 

Development, 6100 Executive Boulevard, 

Room 5B01, Bethesda, MD 20892–9304. (301) 

435–6680. skandasa@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: May 26, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13482 Filed 6–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of Biotechnology Activities; 

Recombinant DNA Research: 

Amended Notice of Meeting 

ACTION: Notice of cancellation of 

consideration of a proposed action 


srobinson on DSKHWCL6B1PROD with NOTICES