75988 Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance 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. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Andre Raw, Center for Drug Evaluation 

and Research (HFD–620), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

5758.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘ANDAs: Pharmaceutical Solid 

Polymorphism; Chemistry, 

Manufacturing, and Controls 

Information.’’ This draft guidance 

provides: (1) A framework for making 

regulatory decisions on drug substance 

sameness in terms of polymorphic form, 

and (2) decision trees which provide a 

recommended course to monitor and 

control polymorphs in the drug 

substance and/or drug product when the 

drug substance exists in relevant 

polymorphic forms.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on pharmaceutical solid polymorphism. 

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. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of any comments 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. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: December 11, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–27736 Filed 12–17–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; The Framingham 

Study

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of the Management and Budget (OMB) 

a request for review and approval the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on March June 30, 2004, page 

39486, and allowed 60-days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. 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: The 

Framingham Study. Type of Information 

Collection Request: Reinstatement of a 

currently approved collection (OMB No. 

0925–0216). Need and Use of 

Information Collection: This study will 

conduct examinations and morbidity 

and mortality follow-up in original, 

offspring, and third-generation 

participants to study the determinants 

of cardiovascular disease. Frequency of 

Response: The participants will be 

contacted annually. Affected Public:

Individuals or households, businesses 

or other for profit, small businesses or 

organizations. Type of Respondents:

Adult men and women; doctors and 

staff of hospitals and nursing homes. 

The annual reporting burden is as 

follows: Estimated Number or 

Respondents: 5,649; Estimated Number 

of Responses Per Respondent: 2.29; 

Average Burden Hours Per Response:

0.6; and Estimated Total Annual Burden 

Hours Requested: 6,886. There are no 

capital, operating or maintenance costs 

to report.

Type of respondents 

Estimated 

number of respondents 

Estimated 

number of responses per 

respondent 

Average burden hours per 

response 

Estimated total 

annual burden 

hours requested 

Participants ...................................................................................................... 3,513 2.86 0.606 6,085

Physician, hospital, nursing home staff ........................................................... 1,068 1.0 0.67 716

Participant’s next of kin ................................................................................... 1,068 1.0 .08 85

Total .......................................................................................................... 6,649 2.29 ........................ 6,886

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate 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) evaluate 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) enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) minimize the burden 

of the collection of information on those 

Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 75989

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 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. Paul 

Sorlie, NIH, NHLBI, 6701 Rockledge 

Drive, MSC 7934, Bethesda, MD 20892–

7934, or call non-toll-free number (301) 

435–0707 or E-mail your request, 

including your address to: 

SorlieP@nhlbi.nih.gov.

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication.

Dated: December 7, 2004. 

Peter Savage, 

Director, DECA, NHLBI.

[FR Doc. 04–27724 Filed 12–17–04; 8:45 am] 

BILLING CODE 4167–01–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. 

Human Monoclonal Antibodies Against 

Hendra and Nipah Viruses 

Dimiter S. Dimitrov et al. (NCI). U.S. 

Provisional Application filed 1 Nov 

2004 (DHHS Reference No. E–004–2005/

0–US–01); Related to the Phage Display 

Library described in DHHS Reference 

No. E–005–2005/0. 

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing are 

neutralizing human monoclonal 

antibodies against the envelope proteins 

(Envs) of Hendra virus (HeV) and Nipah 

virus (NiV) for uses in immunotherapy, 

vaccine development and as diagnostic 

or research reagents. Monoclonal 

antibody variable region fragments (Fabs 

and scFvs) have been isolated from 

screening a human phage display library 

against the Envs. The phage display 

library (DHHS Ref. No. E–005–2005) is 

useful for screening other viral or cancer 

antigens and can be licensed from 

DHHS under a biological materials 

license. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA). 

Human Antibody Phage Display 

Library 

Dimiter S. Dimitrov et al. (NCI). 

DHHS Reference No. E–005–2005/0—

Research Tool; Related to the 

Monoclonal Antibodies Against Hendra 

and Nipah Viruses described in U.S. 

Provisional Application filed 1 Nov 

2004 (DHHS Reference No. E–004–2005/

0–US–01).

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing as a biological 

material for either internal use or 

commercial distribution is a human Fab

immunoglobulin/antibody fragment 

phage display library. The library 

contains 1010 Fabs derived from the 

peripheral blood of ten (10) healthy 

human donors. The high quality of the 

library was demonstrated in the 

successful selection of high affinity 

antibodies specific for Hendra and 

Nipah viruses; however, the library is 

useful for selecting a variety of antigen 

specific immunoglobulin/antibody Fab

fragments especially for cancer or 

viruses. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA). 

Vaccines Against Crimean-Congo 

Hemorrhagic Fever 

Dimiter Dimitrov and Xiadong Xiao 

(NCI). U.S. Provisional Patent 

Application filed 3 Nov 2004 (DHHS 

Reference Nos. E–299–2004/0–US–01 

and E–299–2004/1–US–01). 

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Crimean-Congo hemorrhagic fever 

(CCHF) is a tick-borne public health 

concern in many regions of the world 

including Africa, the Middle East, 

Europe, and Western Asia. The disease 

is etiologically linked to Crimean-Congo 

hemorrhagic fever virus (CCHFV) from 

the Nairovirus genus of the 

Bunyaviridae family of viruses and is 

transmitted primarily through the bite of 

Ixodid ticks. Available for licensing and 

commercial development are antigens, 

immunogens, and nucleic acid 

constructs for the development of 

vaccines against CCHFV. The antigens 

and immunogens are peptides 

corresponding to the soluble 

ectodomains of CCHFV G1 (Gc) and G2 

(Gn) glycoproteins. Also provided are 

coupled proteins that include soluble 

peptide fragments derived from the G1 

(Gc) or G2 (Gn) ectodomains or portions 

thereof; peptidomimetics; vaccines; 

immunogenic compounds methods for 

vaccination and inhibitors of CCHFV 

cell entry. Expression vectors and DNA 

vaccines encoding these peptides are 

also within the scope of the invention 

as well as antibodies, aptamers and kits 

containing antibodies or aptamers that 

bind to these peptides. CCHFV has been 

implicated as a pathogen of biodefense 

significance. 

Intracellular Contrast Agents for 

Magnetic Resonance Imaging 

Mrinal K. Dewanjee (NIHCC). U.S. 

Provisional Patent Application filed 8 

Oct 2004 (DHHS Reference No. E–291–

2004/0–US–01). 

Licensing Contact: Michael 

Shmilovich; 301/435–5019; 

shmilovm@mail.nih.gov.

Available for licensing and 

commercial development are contrast 

agents for magnetic resonance imaging 

(MRI). These agents are composed of 

charge neutral and lipid-soluble 

complexes of paramagnetic cations 

bound by chelators. Unlike 

conventional extra-cellular contrast 

agents, these agents of the present