Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Notices 63159

applicability of the Federal Import Milk 

Act (FIMA) to imported milk and cream.

DATES: Submit written or electronic 

comments on the draft revised CPG by 

November 29, 2004. General comments 

on agency guidance documents are 

welcome any time.

ADDRESSES: Submit written requests for 

single copies of the draft revision of the 

CPG entitled ‘‘Sec. 560.400—Imported 

Milk and Cream—Federal Import Milk 

Act’’ to the Division of Compliance 

Policy (HFC–230), Office of 

Enforcement, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that 

office in processing your request, or fax 

your request to 240–632–6861. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the document.

Submit written comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/

ecomments.

FOR FURTHER INFORMATION CONTACT:

Esther Lazar, Center for Food Safety and 

Applied Nutrition (HFS–306), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740–3835, 

301–436–1485, FAX: 301–436–2632.

SUPPLEMENTARY INFORMATION:

I. Background

The FIMA (21 U.S.C. 141 et seq.) 

prohibits the importation into the 

United States of milk and cream without 

a valid permit from the Secretary of 

Health and Human Services. FDA is 

revising the CPG to clarify and update 

its policy regarding which dairy 

products require permits under the 

FIMA. As explained in the draft CPG, 

FDA intends to consider the following 

dairy products to be subject to the 

FIMA’s permit requirement for 

importation into the United States:

• Milk, lowfat milk, skim milk, 

fortified milk, flavored milk, 

concentrated milk, evaporated milk, 

sweetened condensed milk, ultra 

filtered milk.

• Cream, half-and-half, heavy cream, 

light cream, and light whipping cream.

FDA does not intend to require a 

FIMA permit for the following dairy 

products:

• Sour cream, cultured milk, acidified 

milk, yogurt, cheese, ice cream, and 

eggnog.

• Dried milk, nonfat dry milk, nonfat 

dry milk fortified with vitamins A and 

D, and other dehydrated milk products.

• Any dairy product for which a 

permit is otherwise required, if it has 

been processed and packaged in 

hermetically sealed containers so as to 

be commercially sterile in accordance 

with the requirements of 21 CFR 108.35 

and 21 CFR part 113.

FDA has adopted good guidance 

practices (GGPs) that set forth the 

agency’s policies and procedures for the 

development, issuance, and use of 

guidance documents (21 CFR 10.115). 

The draft guidance is being issued as a 

level 1 draft guidance consistent with 

GGPs. The draft revised CPG represents 

the agency’s current thinking on the 

applicability of the FIMA to imported 

milk and cream. 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 statues 

and regulations.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper 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 Division 

of Dockets Management between 9 a.m. 

and 4.p.m., Monday through Friday.

III. Electronic Access

A copy of the draft revised CPG may 

be downloaded to a personal computer 

with access to the Internet. The Office 

of Regulatory Affairs home page 

includes the draft revised CPG and may 

be accessed at http://www.fda.gov/ora

under ‘‘Compliance Reference.’’

Dated: October 22, 2004.

John Marzilli,

Acting Associate Commissioner for 

Regulatory Affairs.

[FR Doc. 04–24153 Filed 10–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Data Collection; Comment 

Request Survey of Colorectal Cancer 

Screening Policies, Programs, and 

Systems in U.S. Health Plans

SUMMARY: In compliance with the 

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

the Paperwork Reduction Act of 1995, 

for opportunity for public comments on 

proposed data collection projects, the 

National Institutes of Health (NIH), 

National Cancer Institute (NCI) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget for review and 

approval. 

Proposed Collection: Title: Survey of 

Colorectal Cancer Screening Policies, 

Programs, and Systems in U.S. Health 

Plans. Type of Information Collection 

Request: New. Need and Use of 

Information Collection: This study will 

obtain information on policies, 

programs, and practices for colorectal 

cancer screening among health plans in 

the U.S. The purpose of the study is to 

assess (1) Health plan policies, 

programs, and practices for colorectal 

cancer screening; (2) health plan 

activities in response to the National 

Committee on Quality Assurance’s new 

Health Employer Data Information Set 

measure for colorectal cancer screening; 

and (3) characteristics of health plans 

and plan policies and activities that may 

be associated with higher rates of 

colorectal cancer screening. A 

questionnaire will be administered by 

mail or Internet using a national sample 

of health plans. Study participants will 

be health plan medical directors or 

administrators, and they will select their 

preferred response mode. Burden 

estimates are as follows:

Estimated number respondents 

Estimated number responses 

per respondent 

Average burden 

hours per response 

Estimated total 

annual burden 

hours 

520 ......................................................................................................................................... 1 0.333 173 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(a) Whether the proposed collection of 

information is necessary for the 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

63160 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Notices 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology.

FOR FURTHER INFORMATION CONTACT:

Send comments to Carrie N. Klabunde, 

Ph.D., Epidemiologist, National Cancer 

Institute, EPN 4005, 6130 Executive 

Boulevard, Bethesda, Maryland 20892–

7344. Telephone: (301) 402–3362; Fax: 

(301) 435–3710 E-mail: ck97b@nih.gov.

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60-days of the date of 

this publication.

Dated: October 18, 2004

Rachelle Ragland-Green, 

NCI Project Clearance Liaison, National 

Institutes of Health.

[FR Doc. 04–24165 Filed 10–28–04; 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 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 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. 

Mouse Monoclonal Antibody (4G11) 

Against Insulin-Like Growth Factor I 

Receptor 

Peter Nissley, Peta-Gay Jackson-Booth, 

Cheryl Terry, Brett Lackey, Martyna 

Lopaczynska (NCI) 

DHHS Reference No. E–342–2004/0–

US–01 

Licensing Contact: John Stansberry; 

(301) 435–5236; 

stansbej@mail.nih.gov.

The insulin-like growth factor I 

receptor (IGF–IR) is emerging as a 

molecular target for cancer treatment. 

Prospective studies in humans provide 

evidence for a relationship between 

circulating levels of both IGF–I and IGF 

binding protein 3 (IGFBP–3) and the 

risk for the development of cancers of 

the prostate, breast, lung, and colon. 

Many human cancers express or overexpress components of the IGF signaling 

pathway, in particular IGF–II and the 

IGF–I receptor. This technology 

describes a mouse monoclonal antibody 

that binds the insulin-like growth factor 

I receptor. The IGF–IR monoclonal 

antibody 4G11 blocks binding of IGF–I 

to its receptor and promotes down 

regulation of the receptor in MCF–7 

breast cancer cells, MG–63 

osteosarcoma cells and a panel of colon 

cancer cells. Additionally, 4G11 

stimulated down-regulation of the IGF–

I receptors in MCF–7 cells results in 

inhibition of Akt and MAPK activation 

by IGF–I. This monoclonal antibody has 

utility as a laboratory reagent for 

immunoprecipitations, and as an 

inhibitor of the IGF–I signaling 

pathway. A humanized form of 

monoclonal antibody 4G11 would 

potentially have utility as a therapeutic 

to treat a variety of cancers in which 

IGF–IR signaling has been shown to be 

important. This research is partially 

described in Horm Metab Res 2003; 35: 

850–856.

Beta-Glucuronidase Cleavable Prodrugs 

of O6-Alkylguanine-DNA 

Alkyltransferase Inactivators 

Robert C. Moschel et al. (NCI) 

U.S. Provisional Application filed 08 

Sep 2004 (DHHS Reference No. E–

307–2004/0–US–01) 

Licensing Contact: George Pipia; (301) 

435–5560; pipiag@mail.nih.gov.

The present invention relates to 

prodrugs of inactivators of O6-

alkylguanine-DNA alkyltransferase. The 

prodrugs are cleaved by the betaglucuronidase enzyme found in tumor 

cells or co-administered to the patient, 

and the drugs are targeted for use in 

cancer treatment in combination with 

antineoplastic alkylating agent such as 

1,3-bis(2-chloroethyl)-1-nitrosouria or 

temozolomide. 

Transcytosis of Adeno-Associated 

Viruses 

John A. Chiorini and Giovanni Di 

Pasquale (NIDCR) 

U.S. Provisional Application filed 08 

Sep 2004 (DHHS Reference No. E–

298–2004/0–US–01) 

Licensing Contact: Jesse Kindra; (301) 

435–5559; kindraj@mail.nih.gov.

The invention relates to a method for 

delivering nucleic acids to a variety of 

cells including those of the gut, kidney, 

lung and central nervous system. The 

underlying cells of such organs are 

covered by a barrier of endothelial or 

epithelial cells which can limit the 

transfer of nucleic acids, or other 

potentially therapeutic agents, to the 

underlying target cells. To overcome 

this limitation, the method employs 

certain members of the parvovirus 

family to transcytose the barrier cells. 

During transcytosis, the virus passes 

through these barrier cells and can 

infect cells of the underlying layer. 

Therefore, this method could facilitate 

the transfer of nucleic acids to cells that 

currently available viral vectors are 

unable to reach. 

The method could be applied to the 

treatment of neurodegenerative diseases 

such as Parkinson’s, Alzheimer’s, 

Huntington’s, lysosomal storage 

diseases, the dominant spinal cerebellar 

ataxias, and Krabbe’s disease without 

the need for stereotactic injection. The 

method could potentially also be used 

in the treatment of genetic muscle 

disorders such as muscular dystrophy. 

Several of the viruses described in the 

invention are serologically distinct and 

could be used in patients who have 

developed an immune response to other 

vectors. 

Multimeric Protein Toxins to Target 

Cells Having Multiple Identifying 

Characteristics 

Stephen Leppla (NIAID), Shi-hui Liu 

(NIAID), and Thomas Bugge (NIDCR) 

U.S. Provisional Application No. 60/

543,417 filed 09 Feb 2004 (DHHS 

Reference No. E–059–2004/0–US–01) 

Licensing Contact: Brenda Hefti; (301) 

435–4632; heftib@mail.nih.gov.

This technology relates to multimeric 

bacterial protein toxins which can be 

used to specifically target cells. 

Specifically, this is a modified 

recombinant anthrax toxin protective 

antigen (PrAg) that has been modified in 

several ways. First, the PrAg can be 

activated both by a metalloproteinase 

(MMP) and by urokinase plasminogen 

activator (uPA). Second, the native PrAg