Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52385 

TABLE 3.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of Standard Reference No. and Date 

10–57 Phakic Intraocular Lenses ANSI Z80.13–2007 

I. Physical Medicine 

16–161 Safety Standard for Platform Lifts and Stairway Chairlifts ASME A18.1–2005 

J. Sterility 

14–255 Standard Terminology Relating to Flexible Barrier Packaging ASTM F17–07a 

IV. List of Recognized Standards 

FDA maintains the agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http:// 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will incorporate the modifications and 

minor revisions described in this notice 

into the database and, upon publication 

in the Federal Register, this recognition 

of consensus standards will be effective. 

FDA will announce additional 

modifications and minor revisions to 

the list of recognized consensus 

standards, as needed, in the Federal 

Register once a year, or more often, if 

necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under the new provision of 

section 514 of the act by submitting 

such recommendations, with reasons for 

the recommendation, to the contact 

person (see FOR FURTHER INFORMATION

CONTACT). To be properly considered 

such recommendations should contain, 

at a minimum, the following 

information: (1) Title of the standard, (2) 

any reference number and date, (3) 

name and address of the national or 

international standards development 

organization, (4) a proposed list of 

devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

VI. Electronic Access 

Persons interested in obtaining a copy 

of ‘‘Guidance on the Recognition and 

Use of Consensus Standards’’ by using 

the Internet. CDRH maintains an entry 

on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions [including 

lists of approved applications and 

manufacturers’ addresses], small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/cdrh/fedregin.html. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) written or 

electronic comments regarding this 

document. Two copies of any mailed 

comments are to be submitted, 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. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

020. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: August 27, 2008. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E8–20939 Filed 9–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0043] 

[FDA No. 225–08–8001] 

Memorandum of Understanding 

Between the Food and Drug 

Administration and the University of 

Pennsylvania 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 

the University of Pennsylvania (Penn). 

The purpose of this MOU is to establish 

terms of collaboration between FDA and 

Penn focused primarily but not 

exclusively, in the areas of translational 

therapeutics, diagnostics, 

bioinformatics, new clinical trial 

models, drug/device co-development, 

and pharmacoepidemiology. Beyond the 

collaborations in the traditional 

academic programs for training, 

research, and outreach, this MOU will 

also include collaborations with Penn 

extended partnerships such as the 

Institute for Translational Medicine and 

Therapeutics which includes the 

Children’s Hospital of Philadelphia, the 

Wistar Institute, and the University of 

Sciences in Philadelphia. 

DATES: The agreement became effective 

on July 24, 2008. 

FOR FURTHER INFORMATION CONTACT: 

For FDA: Wendy R. Sanhai, Office of 

the Commissioner, Office of 

Scientific and Medical Programs 

(HF–18), Food and Drug 


jlentini on PROD1PC65 with NOTICES
52386 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

7867. 

For Penn: Glenn N. Gaulton, PENN 

Medicine, University of 

Pennsylvania, 421 Curie Blvd., 

Philadelphia, PA 19104–6160, 215–

898–2874. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: September 2, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

BILLING CODE 4160–01–S 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52387 


jlentini on PROD1PC65 with NOTICESEN09SE08.038</GPH>
52388 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 


jlentini on PROD1PC65 with NOTICESEN09SE08.039</GPH>
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52389 


jlentini on PROD1PC65 with NOTICESEN09SE08.040</GPH>
52390 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 


jlentini on PROD1PC65 with NOTICESEN09SE08.041</GPH>
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52391 


jlentini on PROD1PC65 with NOTICESEN09SE08.042</GPH>
52392 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 

[FR Doc. E8–20932 Filed 9–8–08; 8:45 am] 

BILLING CODE 4160–01–C 


jlentini on PROD1PC65 with NOTICESEN09SE08.043</GPH>