Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 31791 

Sponsors of ANDAs do not have to 

repeat the extensive clinical testing 

otherwise necessary to gain approval of 

a new drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (§ 314.162 (21 

CFR 314.162)). Under § 314.161(a)(1) (21 

CFR 314.161(a)(1)), the agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

Cysteine HCl is the subject of NDA 

19–523, most recently held by Hospira, 

Inc. (Hospira), and initially approved on 

October 22, 1986. Cysteine HCl is 

indicated for use as an additive to 

amino acid solutions to meet the 

nutritional requirements of newborn 

infants requiring total parenteral 

nutrition (TPN) and of adult and 

pediatric patients with severe liver 

disease who may have impaired 

enzymatic processes and require TPN. It 

can also be added to amino acid 

solutions to provide a more complete 

profile of amino acids for protein 

synthesis. Hospira notified FDA in a 

letter dated May 26, 2005, that it had 

not commercially manufactured and 

marketed Cysteine HCl, and voluntarily 

asked that the NDA be withdrawn. The 

drug product was moved to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book, and FDA 

withdrew approval of NDA 19–523 

effective June 16, 2006 (71 FR 34940). In 

previous instances (see, e.g., 74 FR 

63404, December 3, 2009; 72 FR 9763, 

March 5, 2007; 61 FR 25497, May 21, 

1996), the agency has determined that, 

for purposes of §§ 314.161 and 314.162, 

never marketing an approved drug 

product is equivalent to withdrawing 

the drug from sale. Regulus 

Pharmaceutical Consulting, Inc., 

submitted a citizen petition, dated April 

30, 2008 (Docket No. FDA–2008–P– 

0278), under 21 CFR 10.30, requesting 

that the agency determine whether 

Cysteine HCl was withdrawn from sale 

for reasons of safety or effectiveness. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

Cysteine Hydrochloride Injection, USP, 

7.25%, was not withdrawn for reasons 

of safety or effectiveness. We have also 

independently evaluated relevant 

literature and have found no 

information that would indicate that 

this product was withheld from sale for 

reasons of safety or effectiveness. 

Accordingly, the agency will continue 

to list Cysteine Hydrochloride Injection, 

USP, 7.25%, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. 

ANDAs that refer to Cysteine 

Hydrochloride Injection, USP, 7.25% 

may be approved by the agency if all 

other legal and regulatory requirements 

for the approval of ANDAs are met. If 

FDA determines that the labeling for 

this drug product should be revised to 

meet current standards, the agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: May 27, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13463 Filed 6–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

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 United States 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. 

888-mel: A Target for Anti-Tumor 

Immune Responses 

Description of Invention: Scientists at 

the National Institutes of Health (NIH) 

have developed a human melanoma cell 

line designated 888-mel from the 

resected tumor of a 26-year old 

Caucasian female (patient 888) 

diagnosed with metastatic melanoma, a 

frequently terminal cancer. The 888-mel 

cell line was derived from three separate 

subcutaneous melanoma lesions on the 

patient and possesses many 

characteristics representative of 

melanoma cell lines developed by these 

researchers. Most prominently, the 888- 

mel cell line was used to develop a 

tumor infiltrating lymphocyte (TIL) 

culture with high affinity for the tumor 

cells of patient 888. When the TIL 888 

culture was provided as an autologous 

adoptive immunotherapy treatment to 

patient 888 in combination with 

interleukin-2 (IL–2), a complete 

remission of subcutaneous, lung, and 

mucosal metastases was observed in the 

patient for over three years. 

Since this medical breakthrough, the 

888-mel cell line has been well 

characterized through various laboratory 

procedures and data involving this cell 

line has been published as part of 

numerous articles. Studies have shown 

that the cell line expresses a variety of 

tumor associated antigens (TAAs), 

including tyrosinase, TRP1, TRP2, 

gp100, MART–1, p15, gp75, mutated 

beta-catenin, and p53. However, 888- 

mel does not normally express the 

MAGE 1, 2, or 3 TAAs. Many melanoma 

cell lines are HLA–A2 restricted, but the 

888-mel cell line is HLA–A2 negative. 

The HLA class I typing for this cell line 

is as follows: HLA–A0101, A2402, B55, 

B62, Cw5201, Cw55, DRbl*1502, 

DRbl*1610, DQbl*0601, DRb5*0102, 

DRb5*0203. 888-mel is a validated 

source of HLA class I peptides utilized 

in screens that test the reactivity of TIL 

cultures that are candidates for adoptive 

immunotherapy trials. 888-mel is also a 

standard cell line for studying immune 

responses in cancer, particularly T cell 

responses. Other experiments show that 

roscovitine, a cyclin-dependent kinase 

inhibitor, can induce apoptosis in the 

888-mel cell line, so these cells may be 

useful in various cell death studies. 


srobinson on DSKHWCL6B1PROD with NOTICES
31792 Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 

Applications 

• Research tool for investigating the 

key immune responses required to 

mediate the remission of metastatic 

melanoma in order to identify the 

immune cell types necessary to produce 

an effective immunotherapy. 

• Research tool for investigating the 

tumor associated antigens that 

contribute to the dampening of the 

immune response in many melanoma 

tumors so that researchers can better 

understand how to boost 

immunogenicity against these antigens. 

• Source material for tumor 

associated peptides that could serve as 

melanoma vaccine candidates or 

utilized to determine the reactivity of 

tumor infiltrating lymphocyte (TIL) 

cultures being considered for clinical 

trials. 

• Source material for the 

development of TIL cultures for use in 

adoptive immunotherapy protocols to 

treat melanoma patients. 

Advantages 

• Cell line is derived from a 

melanoma patient that underwent 

complete tumor remission: Immune cell 

cultures capable of treating melanoma 

patients in adoptive immunotherapy 

protocols could be derived from the 

tumor associated antigen epitopes found 

on the 888-mel cell line. This cell line 

may be a source of novel antigenic 

peptides capable of triggering immune 

responses in melanoma patients that 

lead to tumor regression or stabilization. 

888-mel cells have been shown to retain 

many features of primary melanoma 

samples, including the expression of 

common tumor associated antigens. 

• 888-mel is an HLA–A2 negative cell 

line: A majority of the cancer vaccines 

and immunotherapies developed to date 

have focused on utilizing HLA–A2 

restricted tumor epitopes since this HLA 

allele is largely expressed in the human 

population. However, therapies 

restricted to HLA–A2 recognition will 

not be successful in melanoma patients 

that do not express this allele. For these 

patients, additional therapies are 

needed that are directed against 

melanoma tumor epitopes presented by 

different HLA alleles. 

• The 888-mel cell line has been well 

characterized through multiple years of 

study and is a fundamental cell line for 

melanoma studies: The collection of 

tumor associated antigens expressed by 

this cell line have been determined 

through multiple studies, many of 

which were performed by researchers in 

the inventors’ laboratory. A significant 

amount of data has also been compiled 

detailing the immune responses 

triggered by 888-mel cells. 

Inventors: Steven A. Rosenberg (NCI) 

et al. 

Selected Publications 

1. J Weber et al. Expression of the 

MAGE–1 tumor antigen is up-regulated 

by the demethylating agent 5-aza-21- 

deoxycytidine. Cancer Res. 1994 Apr 1; 

54(7):1766–1771. [PubMed: 7511051] 

2. PF Robbins et al. Recognition of 

tyrosinase by tumor-infiltrating 

lymphocytes from a patient responding 

to immunotherapy. Cancer Res. 1994 

Jun 15; 54(12):3124–3126. Erratum in: 

Cancer Res. 1994 Jul 15; 54(14):3952. 

[PubMed: 8205528] 

3. PF Robbins et al. Multiple HLA 

class II-restricted melanocyte 

differentiation antigens are recognized 

by tumor-infiltrating lymphocytes from 

a patient with melanoma. J Immunol. 

2002 Nov 15; 169(10):6036–6047. 

[PubMed: 12421991] 

Patent Status: HHS Reference No. E– 

070–2010/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a Biological Materials 

License Agreement. 

Licensing Contact: Samuel E. Bish, 

PhD; 301–435–5282; 

bishse@mail.nih.gov. 

Collaborative Research Opportunity: 

The Surgery Branch, National Cancer 

Institute, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

carry out genotypic as well as 

phenotypic analysis of the 888-mel cell 

line in order to better understand the 

nature of tumor cells that respond to 

therapy. In addition, this cell line can be 

used as a target of humoral or cell 

mediated immune responses as a part of 

studies characterizing the nature of 

immune responses directed against 

tumor cells. Please contact John Hewes, 

PhD at 301–435–3131 or 

hewesj@mail.nih.gov for more 

information. 

UOK171, A Spontaneous Clear Cell 

Type Renal Cell Carcinoma (ccRCC) 

Human Cell Line Derived From a 

Surgically Removed Tumor 

Description of Invention: Scientists at 

the National Institutes of Health (NIH) 

have developed a renal cell carcinoma 

(RCC) cell line designated UOK171 from 

the resected tumor of a patient 

diagnosed with stage IV high nuclear 

grade clear cell type renal cell 

carcinoma (ccRCC). The UOK171 cell 

line was immortalized spontaneously by 

mincing the resected tumor into pieces 

followed by propagation of the cells 

over more than twenty generations. One 

of the most prominent characteristics of 

this cell line is its intact, nonmutated 

von Hippel-Lindau (VHL) tumor 

suppressor gene. In the majority of 

sporadic and hereditary ccRCC cases, 

the VHL gene is functionally disrupted 

due to hypermethylation or the gene is 

completely lost. Thus, the UOK171 cell 

line is very useful as a positive control 

for VHL gene expression in studies of 

the genetic and molecular mechanisms 

underlying advanced ccRCC, a disease 

for which there is no effective treatment. 

Specifically, this cell line has been used 

as a non-methylated control cell line in 

studying the effects of 5–Aza-dCyd and 

Zebularine on VHL re-expression from 

methylated-VHL cell line models. These 

agents do not affect the methylation 

status of the VHL gene in UOK171. This 

cell line also exhibits decreased 

fibroblast growth factor 5 (FGF5) 

expression, unbalanced chromosome 3 

translocations, translocations involving 

chromosome 14, the losses of 

chromosome 14 and 22, and 

chromosome structural aberration 1(8) 

(q10). UOK171 is also one of the 40- 

member cell lines in the National 

Cancer Institute (NCI) Urologic 

Oncology Branch (UOB) Tumor Cell 

Line Repository. 

Applications 

• Research tool for investigating the 

underlying molecular mechanisms 

contributing to advanced ccRCC, 

including the identification of new RCC 

tumor antigens for immunotherapy. 

• Research tool for studying the 

methylation status of genes involved in 

ccRCC to reveal the genetic processes 

occurring in ccRCC tissues that may 

contribute to advanced disease. 

• Positive control cell line for VHL 

gene expression and function studies, 

including cytogenetics, gene mutation 

research, and examination of 

chromosomal structural abnormalities 

that may contribute to ccRCC. 

• Research tools for testing the 

activity of potential anti-cancer drugs 

against ccRCC, a disease which has no 

effective treatment options. 

• Possible starting material for 

developing a cancer vaccine against 

RCC. 

Advantages 

• Cell line is derived from a ccRCC 

patient: These cell lines are anticipated 

to retain many features of primary 

ccRCC samples and novel ccRCC 

antigens identified from this cell line 

are likely to correlate with antigens 

expressed on human ccRCC tumors. 

Studies performed using these cell lines 

may have a direct correlation to the 

initiation, progression, treatment, and 

prevention of ccRCC in humans. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 31793 

• Expresses a non-mutated VHL gene: 

In the majority of advanced ccRCC 

patients the VHL gene has been mutated 

or deleted. The UOK171 cell line 

represents a tool that can be utilized to 

study the impact of this VHL gene and 

various mutations on advanced ccRCC. 

• Molecular and genetic features are 

well characterized: This cell line is part 

of NCI Urologic Oncology Branch’s 

Tumor Cell Line Repository. The 

inventor has elucidated many physical 

characteristics of the cell line, including 

chromosomal attributes and important 

ccRCC genes, under various conditions. 

Inventor: W. Marston Linehan (NCI). 

Related Publications 

1. WG Alleman et al. The in vitro and 

in vivo effects of re-expressing 

methylated von Hippel-Lindau tumor 

suppressor gene in clear cell renal 

carcinoma with 5-Aza-2′-deoxycytidine. 

Clin Cancer Res. 2004 Oct 15; 

10(20):7011–7021. [PubMed: 15501981] 

2. CP Pavlovich et al. Patterns of 

aneuploidy in stage IV clear cell renal 

carcinoma revealed comparative 

genomic hybridization and spectral 

karyotyping. Genes Chromosomes 

Cancer. 2003 Jul; 37(3):252–260. 

[PubMed: 12759923] 

3. K Hanada et al. Identification of 

fibroblast growth factor-5 as an 

overexpressed antigen in multiple 

human adenocarcinomas. Cancer Res. 

2001 Jul 15; 61(14):5511–5516. 

[PubMed: 11454700] 

4. C Stolle et al. Improved detection 

of germline mutations in the von 

Hippel-Lindau disease tumor 

suppressor gene. Hum Mutat. 1998; 

12(6):417–423. [PubMed: 9829911] 

5. P Anglard et al. Molecular and 

cellular characterization of human renal 

cell carcinoma cell lines. Cancer Res. 

1992 Jan 15; 52(2):348–356. [PubMed: 

1345811] 

Patent Status: HHS Reference No. E– 

033–2010/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a Biological Materials 

License Agreement. 

Licensing Contact: Samuel E. Bish, 

Ph.D.; 301–435–5282; 

bishse@mail.nih.gov. 

Collaborative Research Opportunity: 

The Urologic Oncology Branch, Center 

for Cancer Research, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize UOK171. Please contact 

John Hewes, Ph.D. at 301–435–3131 or 

hewesj@mail.nih.gov for more 

information. 

Delivery of Transthyretin (TTR) Across 

the Blood Brain Barrier as a Treatment 

for Alzheimer’s Disease 

Description of Invention: The 

invention describes products and 

methods of treating Alzheimer’s disease. 

Alzheimer’s disease is characterized by 

the formation of amyloid plaques and 

tangles in areas of the brain critical for 

learning and memory. The products are 

a transthyretin and other blood brain 

barrier impermeable proteins 

transformed into blood brain barrier 

permeable forms by the coupling of an 

Inter-Cellular Adhesion Molecule-1 

(ICAM-1) targeting agent. Transthyretin 

binds to, and inhibits amyloid protein 

from forming plaque deposits. 

Deposition of amyloid is thought to 

underlie the disease pathology of 

Alzheimer’s. Thus, this invention treats 

Alzheimer’s by inhibiting the formation 

of amyloid plaques, which normally 

would result in amyloid plaque 

formation, inflammation, and neuronal 

cell death. 

Applications 

• Therapeutic for Alzheimer’s 

disease. 

• Therapeutic for other amyloidrelated diseases. 

Development Status: Early stage. 

Market: As of 2007 over 5 million 

people in America are living with 

Alzheimer’s disease. 

Inventors: Juan Marugan et al. 

(NHGRI) 

Patent Status: U.S. Provisional 

Application No. 61/286,205 filed 14 Dec 

2009 (HHS Reference No. E–268–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Steve Standley, 

Ph.D.; 301–435–4074; 

sstand@od.nih.gov. 

Collaborative Research Opportunity: 

The NIH Chemical Genomics Center 

(NCGC) is open to collaborating in order 

to further develop this invention. Please 

contact Dr. Juan Marugan at 

maruganj@mail.nih.gov for more 

information about collaborative research 

opportunities. 

Vaccines Comprising Sand Fly Salivary 

Proteins for Control of Leishmania 

Infection 

Description of Invention: This 

invention relates to the use of several 

peptides from the salivary glands of 

various sand fly species for the control 

of leishmania infection. Many of these 

peptides were shown to be effective in 

eliciting potent immune responses in 

animal models and are excellent 

candidates for the development of 

vaccines against the disease. A vaccine 

comprising one of the peptides was 

used to protect mice challenged with 

parasites and salivary gland 

homogenates. A DNA vaccine 

containing the cDNA for this same 

peptide also provided protection that 

lasted at least 3 months after 

immunization and produced both 

intense humoral and delayed-type 

hypersensitivity reactions. Other 

experiments have shown that B celldeficient mice immunized with the 

plasmid vaccine also successfully 

controlled leishmania infection. Current 

in-vivo studies continue to explore the 

use of these sand fly salivary peptides 

for use as animal vaccines. 

Leishmania parasites are transmitted 

to their vertebrate hosts by infected sand 

fly bites. Sand fly saliva helps to 

enhance infection but immunity to the 

saliva protects against the infection, 

allowing the possibility of vaccine 

development. A number of major 

salivary proteins from sand fly species 

such as Lutzomyia longipalpis, 

Phlebotomus ariasi, and Phlebotomus 

perniciosus are claimed in the 

invention. 

Leishmania infection affects as many 

as 12 million people worldwide, with 

1.5–2 million new cases each year. 

Control of this disease will be a major 

milestone for public health efforts in 

endemic areas of the world. The current 

invention provides a potential means to 

achieve widespread vaccination that 

may lead to significantly control of the 

disease in areas such as South America, 

South Asia, and the Mediterranean 

where it is still a significant health 

problem. An effective veterinary vaccine 

will be of benefit to veterinary medicine 

and may pave the way for human 

vaccines against Leishmaniasis. The 

vaccination of animals may also have a 

positive impact on the epidemiology of 

the disease by reducing the number of 

animal reservoirs and the possibility of 

human infection. 

Applications 

• Vaccines to control leishmania 

infection. 

• Use of peptides to elicit potent 

immune responses. 

Development Status: Early stage. 

Inventors: Jesus G. Valenzuela et al. 

(NIAID). 

Related Publications 

1. Oliveira F, Jochim RC, Valenzuela 

JG, Kamhawi S. Sand flies, Leishmania, 

and transcriptome-borne solutions. 

Parasitol Int. 2009 Mar; 58(1):1–5. 

[PubMed: 18768167] 

2. Valenzuela JG, Garfield M, Rowton 

ED, Pham VM. Identification of the most 


srobinson on DSKHWCL6B1PROD with NOTICES
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