Federal Register / Vol. 75, No. 125 / Wednesday, June 30, 2010 / Notices 37819 

trials, which are often used in the 

evaluation of the safety and efficacy of 

a new antibacterial drug. The input from 

this public workshop will help in 

developing topics for further discussion. 

Date and Time: The public workshop 

will be held on August 2, 2010, from 

8:30 a.m. to 5:30 p.m. and on August 3, 

2010, from 8 a.m. to 4 p.m. 

Location: The public workshop will 

be held at the Crowne Plaza Hotel, 8777 

Georgia Ave., Silver Spring, MD 20910. 

Seating is limited and available only on 

a first-come, first-served basis. 

Contact Persons: Chris Moser or Lori 

Benner, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, Office of Antimicrobial 

Products, 10903 New Hampshire Ave., 

Bldg. 22, rm. 6209, Silver Spring, MD 

20993–0002, 301–796–1300. 

Registration: Registration is free for 

the public workshop. Interested parties 

are encouraged to register early because 

space is limited. Seating will be 

available on a first-come, first-served 

basis. To register electronically, e-mail 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to 

abtrialworkshop@fda.hhs.gov. Persons 

without access to the Internet can call 

Chris Moser or Lori Benner at 301–796– 

1300 to register (see Contact Persons). 

Persons needing a sign language 

interpreter or other special 

accommodations should notify 

Christine Moser or Lori Benner at least 

7 days in advance. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing a public workshop 

regarding scientific issues in the design 

and conduct of clinical trials for 

antibacterial drug development. 

Over the past decade, there have been 

public discussions on NI clinical trial 

design and the types of infectious 

disease indications for which the NI 

clinical trial design is appropriate. This 

public workshop will provide 

information on NI trial design, 

approaches to the justification of NI 

margins, and the assessment and timing 

of efficacy endpoints. Challenges in the 

conduct of clinical trials will be 

discussed, including good clinical 

practice and quality system approaches. 

The workshop will include 

presentations and perspectives from 

FDA and from stakeholders involved in 

clinical research. The public workshop 

is intended to provide information for 

and gain perspective from health care 

providers, researchers, academia, 

industry, and regulators on various 

aspects of the design and conduct of 

clinical trials for antibacterial drug 

development. The input from this 

public workshop will help in 

developing topics for further discussion. 

The agency encourages individuals, 

patient advocates, industry, consumer 

groups, health care professionals, 

researchers, and other interested 

persons to attend this public workshop. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://www.

regulations.gov. It may be viewed at the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD. A transcript will also be available 

in either hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(HFI–35), Office of Management 

Programs, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857. 

Dated: June 11, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–15814 Filed 6–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Proposed Information Quality 

Guidelines Policy 

ACTION: Notice and request for public 

comment on Proposed Information 

Quality Guidelines. 

SUMMARY: These guidelines should be 

used to ensure and maximize the quality 

of disseminated information. The 

Department’s guidelines are based on 

the guidelines of the Office of 

Management and Budget (OMB), 

‘‘Guidelines for Ensuring and 

Maximizing the Quality, Objectivity, 

Utility, and Integrity of the Information 

Disseminated by Federal Agencies’’ 67 

FR 8452 (Feb. 22, 2002). The guidelines 

are not intended to be, and should not 

be construed as, legally binding 

regulations or mandates. These 

guidelines are intended only to improve 

the internal management of DHS and, 

therefore, are not legally enforceable 

and do not create any legal rights or 

impose any legally binding 

requirements or obligations on the 

agency or the public. Nothing in these 

guidelines affects any available judicial 

review of agency action. These 

guidelines will serve as the minimum 

standards for quality within the 

Department. DHS Components may 

expand upon these guidelines as 

necessary, and should use these 

guidelines to develop or improve their 

processes for ensuring information 

disseminated by the Components meet 

the quality standards. DHS Components 

should implement processes and 

mechanisms for receiving, reviewing, 

and responding to information request 

that are consistent with these 

guidelines. DHS Components with 

existing directives, instructions, and 

correction processes for information 

quality may continue to use them, 

provided they are consistent with the 

standards and processes established in 

these guidelines. 

The guidelines apply to information 

disseminated to the public in any 

medium including textual, graphic, 

narrative, numerical, or audiovisual 

forms, including information posted on 

the Internet. The guidelines also apply 

to DHS Component-sponsored 

distribution of information—where the 

DHS Component directs a third party to 

distribute information or DHS has the 

authority to review and approve the 

information before release. If the 

Department is to rely on information 

submitted by a third party that 

information would need to meet 

appropriate standards of objectivity and 

utility. 

DATES: Comments are encouraged and 

will be accepted until July 30, 2010. 

Comments: Public comments are 

invited on the information contained in 

the proposed policy. Comments on the 

proposed policy should be submitted 

electronically to 

DHS.INFOQUALITY@DHS.GOV. 

Obtaining a Copy of the Policy: To 

obtain a copy of the policy please 

submit a request to 

DHS.INFOQUALITY@DHS.GOV 

(including your address and telephone 

number). 

FOR FURTHER INFORMATION CONTACT: 

Department of Homeland Security, 

Information Quality Program 

Management Office at 202–447–5959. 

Richard A. Spires, 

Chief Information Officer. 

[FR Doc. 2010–15926 Filed 6–29–10; 8:45 am] 

BILLING CODE 9110–9B–P 

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