Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 70011 

Scanningless Multiphoton Microscopy 

with Diffraction-Limited Axial 

Resolution 

Description of Invention: The 

technology offered for licensing is a 

scanningless multiphoton microscope 

for performing 3-dimensional imaging 

that achieves diffraction-limited 

resolution. The microscope combines 

temporal multiplexing with spatial 

dispersion to achieve diffraction-limited 

resolution without having to 

mechanically scan the sample (a field of 

view up to 30x30 microns). The widefield excitation of the sample allows 

imaging rates in excess to prior art 

multiphoton microscopes while still 

achieving diffraction-limited axial 

resolution. The microscope includes a 

laser source that generates a 

femtosecond laser beam that passes 

through a stair-step optic having a 

variable thickness piece of glass 

arranged such that each ‘‘strip’’ of the 

laser beam is delivered at a different 

relative delay. Each strip exits the stairstep optic and is imaged onto the 

surface of a diffraction grating by two 

imaging lenses and a mirror. The 

diffraction grating sends the different 

wavelengths that compose each 

horizontal strip of the laser beam in 

different directions. Another pair of 

lenses, such as the imaging lens and 

objective lens (e.g., high numerical 

aperture objective) images and demagnifies the surface of the diffractive 

grating into a biological sample that 

causes an excitation to occur in the 

sample. The ensuing excitation 

generates fluorescence in the sample 

confined to the focal plane of the 

objective lens, where the excitation is 

maximized. The fluorescence is 

collected through the objective lens and 

then by a CCD camera. 

Applications: 

• The invention provides a high 

resolution multiphoton microscopy 

device to the laboratory instrumentation 

market. 

• The uses of such a device would 

predominantly be for research in 

biological imaging. 

• The device provides the ability to 

image a large frame rapidly and with 

relatively low energy and thus without 

burning the sample or destroying 

subcellular structures. 

Inventors: Hari Shroff and Andrew 

York (NIBIB). 

Patent Status: U.S. Provisional 

Application No. 61/385,409 filed 22 Sep 

2010 (HHS Reference No. E–105–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contacts: 

• Uri Reichman, Ph.D., MBA; 301– 

435–4616; UR7a@nih.gov. 

• Michael Shmilovich, Esq.; 301– 

435–5019; ShmilovichM@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Biomedical 

Imaging and Bioengineering Section on 

High Resolution Optical Imaging is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

invention. Please contact Dr. Henry 

Eden at edenh@mail.nih.gov for more 

information. 

Myosin-Based Protein-Protein 

Interaction Assay 

Description of Invention: Investigators 

at the National Institute on Deafness and 

Other Communication Disorders 

(NIDCD) have developed an assay for 

the detection of protein-protein 

interactions in living cells. This assay 

uses readily-available reagents and 

straightforward techniques that avoid 

the difficulty of purifying proteins or 

generating antibodies required for other 

binding studies. Proof-of-concept for 

this assay has been demonstrated, and a 

manuscript is in preparation for 

publication. 

This technology utilizes a molecular 

motor, myosin X, which migrates along 

actin filaments within cells. A protein 

fused to a fragment of myosin X will 

carry its binding partners to the cell 

periphery. Since the myosin fusion 

protein and its partner are labeled with 

different fluorescent tags, an 

unambiguous fluorescence overlap will 

be visible as discrete points along the 

periphery of the cell. The inventors 

have designed a number of cDNAs for 

the construction of fusion proteins 

appropriate for such an assay. 

Available for licensing are a variety of 

cDNAs which may be used for 

generating fluorescently-tagged myosin 

X fusion proteins, for use in the assay 

described above. Also available are a 

number of constructs incorporating 

other fluorescently-tagged myosins, 

kinesins, myosin and kinesin binding 

partners and a variety of PDZ scaffold 

proteins. Further details of the available 

cDNAs are available upon request. 

Applications: 

• Identification of protein-protein 

binding interactions in living cells. 

• DNA-based tools for study of 

myosins, trafficking, signaling 

complexes and other research focusing 

on molecular motors. 

Advantages: 

• Assay avoids the need to purify 

proteins or generate antibodies for 

binding studies. 

• Protein-protein interactions can be 

unambiguously identified. 

Development Status: Proof of concept 

has been demonstrated. 

Inventors: Erich T. Boger, Inna A. 

Belyantseva, Thomas B. Friedman 

(NIDCD). 

Relevant Publication: Belyantseva IA 

et al. Myosin-XVa is required for tip 

localization of whirlin and differential 

elongation of hair-cell stereocilia. Nat 

Cell Biol. 2005 Feb;7(2):148–156. 

[PubMed: 15654330] 

Patent Status: HHS Reference Nos. E– 

069–2009/0, E–069–2009/1, E–069– 

2009/2, E–069–2009/3, E–069–2009/4, 

E–069–2009/5, E–069–2009/6, and E– 

069–2009/7—Research Tool. Patent 

protection is not being sought for this 

invention. 

Licensing Status: Available for 

licensing under a Biological Materials 

License Agreement. 

Licensing Contact: Tara L. Kirby, 

Ph.D.; 301–435–4426; 

tarak@mail.nih.gov. 

Dated: November 9, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–28847 Filed 11–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0448] 

Guidance for Industry, Mammography 

Quality Standards Act Inspectors, and 

Food and Drug Administration Staff; 

The Mammography Quality Standards 

Act Final Regulations: Modifications 

and Additions to Policy Guidance Help 

System #13; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘The Mammography Quality Standards 

Act Final Regulations: Modifications 

and Additions to Policy Guidance Help 

System #13.’’ This document is intended 

to assist mammography facilities and 

their personnel in meeting the 

requirements of the Mammography 

Quality Standards Act (MQSA) 

regulations. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

mstockstill on DSKH9S0YB1PROD with NOTICES

70012 Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘The Mammography Quality 

Standards Act Final Regulations: 

Modifications and Additions to Policy 

Guidance Help System #13’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health (CDRH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4613, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–847–8149. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Charles Finder, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4646, Silver Spring, 

MD 20993–0002, 301–796–5710. 

SUPPLEMENTARY INFORMATION: 

I. Background 

MQSA (Pub. L. 102–539) was signed 

into law on October 27, 1992, to 

establish national quality standards for 

mammography. It is codified at 42 

U.S.C. 263b. The MQSA requires that, in 

order to lawfully provide 

mammography services after October 1, 

1994, all facilities, except facilities of 

the Department of Veterans Affairs, 

must be accredited by an approved 

accreditation body and certified by the 

Secretary of Health and Human Services 

(the Secretary) or by an approved State 

certification Agency (section 354(b) of 

the MQSA, (42 U.S.C. 263b(b))). In June 

1993, the authority to approve 

accreditation bodies and State 

certification agencies and to certify 

facilities was delegated by the Secretary 

to FDA (June 10, 1993, 58 FR 32543). On 

October 28, 1997, FDA first published 

final regulations implementing the 

MQSA in the Federal Register (part 900 

(21 CFR part 900)). The MQSA has 

twice been amended since its 

enactment, through the Mammography 

Quality Standards Reauthorization Acts 

of 1998 and 2004 (Pub. L. 105–248 and 

108–365). 

This guidance updates the Policy 

Guidance Help System (PGHS) and 

addresses or contains the following: 

1. Updated contact information for 

accreditation bodies and certification 

agencies; 

2. General guidance regarding 

Additional Mammography Reviews; 

3. Previously approved alternative 

standards; 

4. Centers for Medicare and Medicaid 

Services reimbursement; 

5. Mechanisms to inform physicians 

and patients of mammography results; 

6. Mammographic modality and its 

impact on personnel requirements; 

7. Clarification of the personnel 6- 

month exemption period; 

8. Information on calibrating the air 

kerma measuring instrument; 

9. Medical physicist involvement as it 

applies to cassette replacement; 

10. Full Field Digital Mammography 

(FFDM) and use of single-use cushion 

pads; 

11. Quality control testing of 

computer controlled compression 

devices; 

12. Mammography equipment 

evaluations of laser printers; 

13. Quality control testing of monitors 

and laser printers; 

14. Mammography equipment 

evaluations of new FFDM units; and 

15. Mammography equipment 

evaluations of off-site laser printers and 

monitors. 

The draft of this guidance was made 

available in the Federal Register of 

October 9, 2009 (74 FR 52242). The 

comment period closed on January 7, 

2010. During the public comment 

period, 4 respondents submitted a total 

of 14 comments. In addition, the 

National Mammography Quality 

Assurance Advisory Committee 

reviewed the draft guidance during its 

January 25, 2010, meeting and provided 

additional comments. FDA reviewed 

and considered all the comments and in 

response FDA has modified the draft 

guidance as follows by: 

1. Providing the most current 

accreditation body and certification 

Agency contact information; 

2. Clarifying that original or lossless 

compressed digital image files may be 

acceptable for record transfer; 

3. Clarifying the conditions under 

which an Additional Mammography 

Review conducted by an outside entity 

would be acceptable to FDA; 

4. Deleting the question and answer 

dealing with image labeling; 

5. Modifying the section on the use of 

attestation to include attesting to the 

specific mammographic modality 

included in personnel’s initial training; 

6. Clarifying the guidance on the use 

of non-invasive kilovolts peak (kVp) 

meters; and 

7. Recommending the inclusion of 

cushion pad(s) when performing 

automatic exposure control testing. 

In November 1998, FDA compiled all 

to-date final FDA guidances related to 

MQSA and put them into a 

computerized searchable database 

called the PGHS. The PGHS is available 

on the Internet at: http://www.fda.gov/

Radiation-EmittingProducts/

MammographyQualityStandardsAct

andProgram/Guidance/

PolicyGuidanceHelpSystem/

default.htm. 

FDA periodically updates the 

information in the PGHS and this 

document serves as a further update. 

Individuals wishing to receive 

automatic notification of future updates 

may subscribe to our E-mail ListServ by 

visiting http://service.govdelivery.com/

service/subscribe.html?code=USFDA_45 

and following the directions. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking. 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 statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘The Mammography Quality 

Standards Act Final Regulations: 

Modifications and Additions to Policy 

Guidance Help System #13,’’ you may 

either send an e-mail request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1695 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act 

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 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 70013 

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

3520). The collections of information in 

part 900 have been approved under 

OMB control number 0910–0309. 

V. 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. 

Dated: November 10, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–28762 Filed 11–15–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1344–CN] 

RIN 0938–AP89 

Medicare Program; Inpatient 

Rehabilitation Facility Prospective 

Payment System for Federal Fiscal 

Year 2011; Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Correction notice. 

SUMMARY: This document corrects a 

technical error that appeared in the 

notice published in the July 22, 2010 

Federal Register entitled, ‘‘Inpatient 

Rehabilitation Facility Prospective 

Payment System for Federal Fiscal Year 

2011.’’ 

DATES: Effective Date. This correction is 

effective for IRF discharges occurring on 

or after October 1, 2010 and on or before 

September 30, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Susanne Seagrave, (410) 786–0044. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2010–17621 of July 22, 

2010 (75 FR 42836), there was a 

technical error that we are identifying 

and correcting in the ‘‘Correction of 

Errors’’ section below. The provisions in 

this correction notice are effective as if 

they had been included in the document 

published July 22, 2010. Accordingly, 

the corrections are effective October 1, 

2010. 

II. Summary of Errors 

In the July 22, 2010 notice (75 FR 

42836), we applied our established 

formula for calculating the national 

cost-to-charge (CCR) ceiling. Using that 

formula, the national CCR ceiling 

should have been calculated to be 1.61. 

It was inadvertently listed on page 

42856 as 2.94 due to a calculation error. 

Thus, we are correcting page 42856 to 

reflect the correct result of the 

application of the established formula. 

The corrected national CCR ceiling is 

1.61 for FY 2011. 

III. Correction of Errors 

In FR Doc. 2010—17621 of July 22, 

2010 (75 FR 42836), make the following 

corrections: 

1. On page 42856, in column 1, in line 

23 from the top of the page, the value 

‘‘2.94’’ is corrected to read ‘‘1.61.’’ 

2. On page 42856, in column 1, in line 

25 from the top of the page, the value 

‘‘2.94’’ is corrected to read ‘‘1.61.’’ 

IV. Waiver of Proposed Rulemaking 

and Delayed Effective Date 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register to provide a period for public 

comment before the provisions of a rule 

take effect in accordance with section 

553(b) of the Administrative Procedure 

Act (APA) (5 U.S.C. 553(b)). We also 

ordinarily provide a 30-day delay in the 

effective date of the provisions of a rule 

in accordance with section 553(d) of the 

APA (5 U.S.C. 553(d)). However, we can 

waive both notice and comment 

procedures and the 30-day delay in 

effective date if the Secretary finds, for 

good cause, that such procedures are 

impracticable, unnecessary, or contrary 

to the public interest, and incorporates 

a statement of the finding and the 

reasons into the notice. 

The policies and payment 

methodology expressed in the FY 2011 

IRF PPS notice (75 FR 42836) have 

previously been subjected to notice and 

comment procedures. This correction 

notice merely provides a technical 

correction to the FY 2011 notice, and 

does not make substantive changes to 

the policies or payment methodologies 

that were expressed in that notice. 

Therefore, we find it unnecessary to 

undertake further notice and comment 

procedures with respect to this 

correction notice. We also believe that it 

is in the public interest (and would be 

contrary to the public interest to do 

otherwise) to waive notice and comment 

procedures and the 30-day delay in 

effective date for this notice. This 

correction notice is intended to ensure 

that the FY 2011 IRF PPS notice 

accurately reflects the payment 

methodologies and policies expressed in 

the notice, and that the correct 

information is made available to the 

public. Therefore, we find good cause to 

waive notice and comment procedures 

and the 30-day delay in the effective 

date for this correction notice. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 9, 2010. 

Dawn L. Smalls, 

Executive Secretary to the Department. 

[FR Doc. 2010–28814 Filed 11–15–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

President’s Cancer Panel. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: President’s Cancer 

Panel. 

Date: December 14, 2010. 

Time: 8 a.m. to 4:45 p.m. 

Agenda: The Future of Cancer Research: 

Accelerating Scientific Innovation. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, 6C10, Bethesda, 

MD 20892. 

Contact Person: Abby B. Sandler, PhD, 

Executive Secretary, Chief, Institute Review 

Office, Office of the Director, 6116 Executive 

Blvd., Suite 220, MSC 8349, National Cancer 

Institute, NIH, Bethesda, MD 20892–8349, 

(301) 451–9399, sandlera@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

mstockstill on DSKH9S0YB1PROD with NOTICES