21270 Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices 

the submission of information and 

verification of patent information to 

ensure not only that the patent contains 

drug substance, drug product, or 

method of use claims, but that the 

patent claims the drug substance, drug 

product, or method of using the drug 

product for which approval is sought or 

has been granted. The clarification that 

you have requested would require 

revision of FDA’s regulations. FDA will 

further consider your request for 

clarification and revision to the 

regulations in the context of the 

rulemaking referenced previously. 

Finally, the comment stated that the 

submission of FDA Forms 3542a and 

3542 with submission and upon 

approval, respectively, of an NDA 

supplement is redundant where the 

information has not changed since the 

form last was filed, imposes a burden on 

sponsors, and serves no statutory 

purpose. 

(Response) FDA’s regulation at 

§ 314.53(b)(1) requires any applicant 

who submits to FDA a supplement to an 

approved application that meets the 

criteria of § 314.53(d)(2) to submit FDA 

Forms 3542a and 3542, as appropriate. 

The revision that you have proposed 

would require revision of FDA’s 

regulations. FDA will further consider 

your request for clarification and 

revision to the regulations in the context 

of the rulemaking referenced previously. 

FDA estimates that the collection of 

information resulting from these 

regulations is as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

FDA Form No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Form FDA 3542a 114 3.2 365 20 7,300 

Form FDA 3542 96 3.2 308 5 1,540 

Total 8,840 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: April 23, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8141 Filed 4–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0155] 

Defining and Implementing Quality in 

Clinical Investigations: From Design to 

Completion; Public Workshop; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

cosponsored with the Drug Information 

Association (DIA) entitled ‘‘Defining 

and Implementing Quality in Clinical 

Investigations: From Design to 

Completion.’’ The purpose of the public 

workshop is to solicit constructive 

information on identifying attributes of 

quality in clinical investigations, 

approaches to quality from design to 

completion, and methods for measuring 

quality and ensuring data integrity 

during the conduct of clinical 

investigations. The public workshop 

will discuss the definition of quality, 

mechanisms for implementing quality 

in clinical investigations, and methods 

to improve the accuracy and reliability 

of collected data, which will enhance 

human subject protection. FDA also is 

requesting comments on these topics. 

Dates and Time: The public workshop 

will be held on May 10 and May 11, 

2007, from 8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Washington Marriott 

Hotel, 1221 22d St. NW., Washington, 

DC 20037. 

Contact Person: Kathleen Donner, 

DIA, 215–293–5810, FAX: 215–442–

6199, or e-mail: 

Kathleen.Donner@diahome.org. 

Registration: Registration will be 

accepted by mail, fax, or e-mail until 

May 10, 2007, and also onsite. Mail, fax, 

or e-mail your registration information 

(including name, title, firm name, 

address, telephone, and fax numbers) to 

the contact person (see Contact Person). 

You may also register online at 

www.diahome.org (‘‘Educational 

Offerings,’’ keyword 07013). (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) There is a registration fee for 

the workshop: $1,165.00 for industry, 

$475.00 for charitable nonprofit 

organizations or academia, and $200.00 

for Federal Government employees. The 

registration fees will be used to cover 

costs of the workshop, including 

program materials and food. 

If you need special accommodations 

due to a disability, please contact 

Kathleen Donner (see Contact Person) at 

least 7 days in advance. 

Comments: The deadline for 

submitting comments regarding this 

public workshop is July 10, 2007. 

Interested persons may submit written 

or electronic 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. 

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. 

SUPPLEMENTARY INFORMATION: The 

purpose of the public workshop entitled 

‘‘Defining and Implementing Quality in 

Clinical Investigations: From Design to 

Completion’’ is to solicit constructive 

information on identifying attributes of 

quality in clinical investigations, 

approaches to quality from design to 

completion, and methods for measuring 

quality and ensuring data integrity 

during the conduct of clinical 

investigations. 

Over time, clinical investigations have 

evolved dramatically. In particular, 

clinical investigations are no longer 

primarily conducted at a single center; 

the use of electronic recordkeeping in 

the studies has increased dramatically; 

and the conduct of clinical 

investigations has become more 

complex. The public workshop will 

address the challenges of and potential 

solutions for maintaining quality during 

the conduct of clinical investigations to 

protect human subjects. The following 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices 21271 

topics will be discussed: (1) The 

definition of quality, (2) mechanisms for 

implementing quality in clinical 

investigations, and (3) methods to 

improve the accuracy and reliability of 

collected data. As part of the Human 

Subject Protection/Bioresearch 

Monitoring Initiative (http:// 

www.fda.gov/ oc/ initiatives/ 

criticalpath/), this public workshop 

will help improve the safe conduct of 

clinical investigations and maximize 

efficiency in clinical investigations 

without compromising quality. 

Dated: April 23, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8137 Filed 4–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–07–8001] 

Memorandum of Understanding 

Between the National Cancer Institute 

and the Food and Drug Administration 

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 National Cancer Institute (NCI), part 

of the National Institutes of Health of 

the Department of Health and Human 

Services. The purpose of this MOU is to 

establish a formal collaboration between 

FDA and NCI regarding proteomics 

science and technology to accelerate 

proteomics technology development 

and application in clinical settings. FDA 

and NCI intend to collaborate in areas 

involving proteomics such as: Sample 

collection, preparation, storage and 

processing; bioinformatics and data 

analysis; discovery and validation of 

biomarkers; and surrogate biomarkers of 

cancer development and drug response, 

including standardization among 

technology platforms and assay 

standards development. 

DATES: The agreement became effective 

April 5, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Francis Kalush, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 

Gaither Rd., Rockville, MD 20850, 

240–276–0996, e-mail: 

francis.kalush@fda.hhs.gov. 

or Henry Rodriguez, Office of the 

Director, (MSC–2580), National 

Cancer Institute, 31 Center Dr., rm. 

10A52, Bethesda, MD 20892, 301–

496–1550. 

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: April 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S 


rwilkins on PROD1PC63 with NOTICESEN30AP07.017</GPH>